Reported trial results for Hearing Loss
Every Hearing Loss trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
78 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT02819856 · results posted 25 June 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT02819856) enrolled 35 people in total across four groups. Eight people received a placebo capsule (containing no active ingredient), while the remaining 27 received different doses of a capsule called SPI-1005, which contains a compound called ebselen — with groups taking one, two, or three 200mg capsules respectively. Most participants completed the trial, with a small number (four in total across all groups) not finishing. The trial was measuring changes in hearing and balance that can sometimes occur as a side effect of certain medical treatments — a problem known as ototoxicity — as well as changes in lung function. The reported data shows the following counts of participants who met the threshold for a meaningful change in each measure. For hearing loss detected by a standard hearing test (pure-tone audiometry), the numbers were: 7 out of 7 completers in the placebo group, 6 out of 7 in the one-capsule group, 4 out of 9 in the two-capsule group, and 3 out of 8 in the three-capsule group. For a separate inner-ear sound test (otoacoustic emissions), the numbers showing a meaningful decrease were 4, 5, 4, and 5 across the four groups. For a speech-in-noise test, the numbers showing a meaningful drop in score were 4, 2, 1, and 2. For tinnitus (ringing in the ears) severity scores, no participants in any group met the threshold for a meaningful increase. For vertigo (dizziness) scores, 0, 2, 0, and 0 participants met the threshold across the groups. For lung function, the reported average change from the start of the trial (in litres per second) was +0.33 for placebo, +0.06, +0.14, and +0.13 for the three ebselen dose groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05709223 · results posted 15 May 2026
According to the results reported on ClinicalTrials.gov, this trial involved 17 people who had received a cochlear implant. Nine participants started in one order of hearing programmes and eight started in the other, with 13 people completing the trial overall. The trial was comparing two different ways of setting up ("fitting") a cochlear implant's sound programme: one based on behavioural testing (how a person responds to sounds in a clinic) and another based on a method called categorical loudness scaling (where a person rates how loud sounds seem to them). The study measured how well participants could understand speech in quiet and in noisy situations, as well as their own ratings of hearing quality in daily life. The reported data shows that for understanding single words spoken in quiet at a soft volume (50 dB SPL, roughly the level of a quiet conversation), participants scored an average of about 35.6% correct words with the behavioural programme and about 37.2% correct words with the loudness scaling programme — a difference of approximately 1.5 percentage points. For understanding sentences in noisy surroundings, the reported scores were 5.73 dB and 6.02 dB respectively, a difference of about 0.29 dB (a smaller number here generally means better performance in noise). For a secondary measure of word understanding at a slightly louder volume (60 dB SPL), scores were around 42.8% and 39.2% correct. A separate noise test using number sequences showed scores of approximately −3.94 dB and −3.95 dB, a difference of essentially zero. Participants' own ratings of their hearing in everyday life (on a scale of 0 to 10, where 10 is perfect) averaged around 5.41 with one programme and 5.32 with the other — a difference of about 0.09 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03336398 · results posted 25 March 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 42 people who had tinnitus (ringing or noise in the ears). The study was measuring levels of two brain chemicals — GABA and Glutamate (also called Glx) — in the part of the brain involved in hearing (the auditory cortex). These chemicals were measured using a specialised brain scanning technique called Magnetic Resonance Spectroscopy (MRS), which can detect chemical signals in the brain without surgery. Participants received both a ketamine infusion (a drug being investigated) and a saline (salt water) infusion on separate occasions, so their brain chemical levels could be compared under each condition. Of the 42 people who started, 39 completed the study. The reported data shows GABA levels (measured as a ratio relative to water in the brain tissue) across eight time points — the first two recorded before the infusion as a baseline, and the remaining six recorded during and after the infusion over 40 minutes. The reported GABA ratio values across those eight time points ranged from approximately 2.03 to 2.14. The results appear relatively stable across the time points measured. Secondary outcome measure results were not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04610112 · results posted 25 March 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04610112) enrolled 30 participants, all of whom completed the study — none dropped out. The trial was measuring hearing performance using two standard hearing tests: one that checks how well people can correctly identify single spoken words in a quiet environment, and another that measures how well people can follow speech when there is background noise. The reported data shows that on the quiet word-recognition test (called the Freiburger Monosyllables Score), participants scored an average of 54.58 out of a possible 100% correct answers. For the background-noise test (the Oldenburg Sentence Test), the reported average result was 1.69 dB SNR — this figure represents the difference in volume (in decibels) between the speech and the background noise at which participants could correctly understand half of what was said; a lower number generally means less difference was needed, though the trial data itself does not interpret this figure further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06298396 · results posted 17 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom used a cochlear implant sound processor. The trial tested different sound processor settings, called MAPs — a standard "Default" setting and three lower-power settings labelled LP1, LP2, and LP3. The study measured how well participants could understand speech in quiet conditions and in noisy conditions when using each of these different settings. Participants went through multiple rounds of testing, and all but one participant completed the full programme of testing across the different settings. The reported data shows that the main (primary) comparisons were between the Default MAP and the LP1 MAP. For understanding speech in quiet, the reported average difference in word scores between these two settings was −0.05 percentage points, meaning the scores were almost identical. For understanding speech in noise, the result is measured using something called a Speech Reception Threshold (SRT) — a lower number here means a person needs less background noise reduction to follow speech. The reported average difference in SRT between Default and LP1 was −0.32 dB, again a very small difference. The secondary comparisons between the lower-power settings (LP1 vs LP2, and LP1 vs LP3) also showed small reported differences — ranging from 0.45 to −1.6 percentage points for quiet listening, and −0.23 to −0.39 dB for noisy listening. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06173687 · results posted 3 December 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06173687) enrolled 51 participants, with 45 completing the study and 6 not completing it. The trial was measuring the stability of electrical readings from a cochlear implant — specifically, how consistent the electrical signals were across the implant's electrode contacts (the small components that deliver sound signals) over an 8-week period. The reported data shows that the primary outcome measured something called "impedance" — this is essentially the resistance to electrical signals across the implant's 22 electrode contacts. The trial tracked how much this resistance varied from day to day over 8 weeks. The reported result was a median variation of 0.36 kOhm (kilohms, a unit of electrical resistance). In plain terms, this number represents the typical amount of day-to-day fluctuation in the electrical readings across the implant's contacts during the study period. No secondary outcome measure data appears to have been reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT04972162 · results posted 30 September 2025
According to the results reported on ClinicalTrials.gov, this trial involved 28 people in total, split into two groups of 14. It used a "crossover" design, meaning every participant tried both approaches — hearing aids fitted using a web app, and hearing aids fitted using the standard clinical method — with a short break in between. Two participants (one from each group) did not complete the washout period between the two stages, so 26 people finished the full trial. The trial was measuring how much benefit people got from each type of hearing aid fitting, using a questionnaire called the APHAB (Abbreviated Profile of Hearing Aid Benefit), which asks about everyday listening situations such as holding a conversation, hearing in background noise, and hearing in reverberant or echoing spaces. The reported data shows benefit scores for three listening situations. In the "ease of communication" category, the web-app-fitted group scored 12.7 and the standard-of-care-fitted group scored 13.18. In the "background noise" category, the scores were 11.17 and 12.22 respectively. In the "reverberation" (echoing environments) category, the scores were 11.43 and 12.49 respectively. On this scale, higher numbers indicate greater reported benefit from hearing aids in that situation. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so no further figures are available to report. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04908631 · results posted 22 August 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment approach combining a form of gentle brain stimulation — called transcranial direct current stimulation, or tDCS, which involves applying a very low electrical current to the scalp — with auditory (hearing) training. The trial was designed to test whether this combined program was practical and manageable for participants, rather than to test whether it produced any particular health outcome. Eight people were enrolled in the single study group, five completed the study, and three did not finish. The reported data shows that 61 people expressed initial interest in the study, and 8 were ultimately enrolled. Of those, 6 participants completed the full tDCS training program, and 7 were observed by a provider to have demonstrated that they could carry out the training correctly. When asked whether the program was easy to complete, 6 participants reported that they agreed or strongly agreed (on a scale where 1 meant strongly disagree and 5 meant strongly agree). The reported data also shows that 0 participants recorded an adverse event (an unexpected negative experience) in their daily diaries. However, 6 participants did experience skin irritation — such as tingling or warmth on the scalp — which the trial notes is a known effect of this type of stimulation. It is important to note that this trial was focused on measuring practical aspects of delivering the program — such as how many people could complete it and follow the steps correctly — rather than measuring whether it produced any change in a health condition. The reported numbers reflect feasibility and participant experience only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05893992 · results posted 17 August 2025
According to the results reported on ClinicalTrials.gov, this trial involved 26 adults with hearing loss, split into two groups of 13. It used a "crossover" design, meaning both groups tried both conditions — listening with a digital noise management feature turned on, and listening in quiet — just in a different order. All 26 participants completed the trial. The study was measuring brain activity in the front part of the brain (using a light-based scanning method called fNIRS, which tracks blood oxygen levels as a rough guide to mental effort and motivation), as well as how accurately people understood speech in noisy conditions, and how much effort participants felt they were putting in while listening. The reported data shows the following numbers for the primary outcome — brain oxygenation measured in the prefrontal cortex. Two figures were recorded for the group with hearing loss: -14.85 and 4.15 (measured in micromoles). The trial report does not clearly label which figure corresponds to which listening condition, so those two numbers are presented here as reported. For the secondary outcomes, the reported data shows speech understanding scores of 75.8% and 62.3% correct words repeated — again, one figure per condition. For the self-rated listening effort (on a scale of 1 to 7, where lower means less effort felt), the reported scores were 3.08 and 4.08. It is worth noting that the trial report does not explicitly label each pair of numbers against the "digital noise management" or "quiet listening" condition in the structured data submitted, so it is not possible from this summary alone to say which number belongs to which condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05619575 · results posted 31 July 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 adults who use a cochlear implant, with 17 completing the study and 3 not completing it. The trial was comparing two versions of the Cochlear CP1170 sound processor — one with a feature called "ForwardFocus" turned on (which is designed to focus on sound coming from in front of the wearer) and one with it turned off — as well as comparing the CP1170 to participants' own existing processors. The main thing being measured was how well participants could understand speech in noisy situations, using a standardised Australian listening test. Researchers also looked at word recognition in quiet, participant satisfaction, and self-reported hearing experiences. The reported data shows that for the primary outcome — understanding speech in noise with sound coming from in front and noise from behind — the ForwardFocus ON condition scored –6.58 dB and the ForwardFocus OFF condition scored –4.58 dB, giving a paired difference of –2.00 dB. (In this type of test, a lower or more negative number means a person needed less favourable listening conditions to understand speech, so the difference between the two conditions was 2.00 dB.) For a similar noise test with slightly different speaker placement, the reported difference was –1.43 dB. For word recognition in quiet, the CP1170 scored 59.06% correct words compared to 56.53% for the existing processor, a difference of 2.53 percentage points. On satisfaction, the reported data shows 16 out of 18 participants expressed being somewhat or very satisfied with the sound quality of the new processor's program. On the self-reported hearing questionnaire (scored 0–10, where higher means better), the average scores were 6.07 for the CP1170 and 6.06 for participants' own processors, a difference of 0.10 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05379231 · results posted 11 June 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all in a single group. The trial was testing different hearing aid set-ups for people with significant hearing loss in one ear. Specifically, it compared two types of device configurations — a BiCROS fitting (which picks up sound from the poorer ear and sends it to the better ear) and a monaural fitting (a hearing aid on the better ear only) — each tested with two different microphone settings (a directional "beamformer" mode and an "omni" mode that picks up sound from all directions). Participants also completed a condition with no hearing aid at all. The trial measured how well people could understand speech in noisy situations, as well as how they rated their own listening experience. The reported data shows the following for the main measurement — understanding speech when noise came from the side of the better ear. Scores are reported as a threshold level (lower/more negative numbers mean speech could be understood at a lower volume relative to the noise, which is generally considered better performance). The BiCROS with beamformer scored −8.8, BiCROS omni scored −3.7, monaural with beamformer scored −9.2, monaural omni scored −2.8, and the unaided condition scored −0.1. For the secondary test using noise from speakers surrounding the participant, the reported scores were −14.2 (BiCROS beamformer), −8.0 (BiCROS omni), −13.9 (monaural beamformer), −9.3 (monaural omni), and −3.4 (unaided). On the subjective questionnaires completed after a home trial of the BiCROS device, the reported average scores on the Speech, Spatial and Qualities of Hearing scale (which runs from −5 to +5, where positive means better than without) were 2.48, 1.16, and 2.55 across three sub-scales, and 2.83 on the Bern Benefit questionnaire (also −5 to +5). For sound quality ratings (scale of 1–10, higher being better), the beamformer conditions scored higher than omni and unaided across both clarity and overall impression. In the preference comparison, the data was not reported in a way that allows a straightforward summary of totals for all categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04242940 · results posted 15 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04242940) involved 14 participants, all of whom completed the study — none dropped out. The trial was testing the Ponto 4 sound processor, a bone-anchored hearing device, and looked at how a feature called OSN (Oticon Speech Navigator, a noise-management setting) affected listeners when it was turned on compared to when it was turned off. The researchers measured several things: how much participants' pupils dilated during listening tasks (pupil dilation is used as an indirect measure of mental effort — bigger dilation is thought to reflect more effort), how well participants could understand speech in noisy conditions, and how participants rated their own hearing experience through questionnaires. The reported data shows that when the OSN setting was turned on compared to off, pupil dilation was reduced by 58.7% at a particular level of background noise (described as +4 dB signal-to-noise ratio, meaning speech was slightly louder than the noise). For peak pupil dilation — the highest point of dilation recorded — the reported values were 1.80 (arbitrary units) with OSN off and 1.05 with OSN on. For speech understanding across five different noise levels, the reported percentage-correct scores with OSN on ranged from approximately 21.7% (in the noisiest condition) up to 97.4% (in the least noisy condition), while with OSN off the scores ranged from approximately 5.8% to 95.8% across those same noise levels. Self-reported hearing quality was measured using the SSQ questionnaire (scored 0–10, where higher is better); scores across the three listening categories and different time points ranged roughly from 3.87 to 6.67. On a preference questionnaire after participants had tried the device in everyday life, 11 out of 14 participants reported a preference for the Ponto 4 test processor, 2 reported a preference for their own existing processor, and none reported no preference — though the data as submitted did not fully clarify all response categories. Aided hearing thresholds (how soft a sound participants could detect while wearing the device) were reported as averages of 32.29 and 37.95 decibels across the tested frequencies. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05258773 · results posted 23 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05258773) enrolled 28 people in total — 18 in the treatment arm (who received a medicine called SENS-401) and 10 in the control arm (who did not). The trial was looking at people undergoing cochlear implant surgery, and it was primarily measuring whether SENS-401 could be detected in the fluid of the inner ear (called perilymph) after seven days of taking the medicine. It also measured drug levels in the blood, and tracked any changes in participants' hearing thresholds (the softest sounds a person can detect) over time. The reported data shows that, of the 15 treatment-arm participants from whom a perilymph sample was taken during surgery, all 15 had detectable levels of SENS-401 in that fluid. As expected, no SENS-401 was detected in the control arm, since those participants did not receive the medicine. For the treatment arm, the reported average concentration of SENS-401 in the inner-ear fluid was approximately 45.8 ng/ml (nanograms per millilitre, a measure of how much of the substance was present), and in the blood it was approximately 59.6 ng/ml. Regarding hearing thresholds, the reported data shows changes from baseline (starting point) measured in decibels (dB) at various time points — a higher number here indicates greater hearing deterioration. At the end of the study (around day 105), the treatment arm showed an average change of approximately 25.6 dB at one frequency, compared to approximately 34.5 dB in the control arm. Similar patterns were seen across other time points and frequency averages, though the data does not include information on statistical significance or variability, so these numbers should be interpreted with care. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04750642 · results posted 22 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04750642) enrolled 29 people in total — 14 in the group receiving the investigational cochlear implant device (called CI632D) and 15 in the group receiving a comparator cochlear implant device. Of those, 13 people in each group completed the study. The trial was primarily measuring electrical resistance (called impedance) inside the implant at six months after surgery — lower resistance is thought to indicate less scar tissue build-up around the implant's electrodes — as well as how participants' ability to understand speech changed compared to before their surgery. The reported data shows that at six months after surgery, the average impedance reading in the investigational device group was 3.99 kOhms (a unit of electrical resistance), compared to 8.66 kOhms in the comparator device group. For speech understanding, the investigational device group showed an average improvement of 39.5 percentage points compared to their own pre-surgery scores. When the two groups were compared directly to each other at six months, the reported data shows the investigational device group scored an average of 57.8% on a word-repetition test (CNC Words in Quiet) and 46.1% on a sentence-repetition test (AzBio Sentences in Quiet), while the comparator group scored 68.0% and 55.3% respectively on those same tests. Regarding device-related unwanted events (things that went wrong and may have been connected to the device), the reported data shows these were recorded across both groups over 12 months, with 2 participants in the investigational group and 3 in the comparator group experiencing at least one such event of a particular category — though the full breakdown across all event categories is complex and the data as submitted includes multiple sub-counts across both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05337748 · results posted 20 March 2025
According to the results reported on ClinicalTrials.gov, this trial involved 68 people in total — 35 in one group and 33 in another. The study compared two different ways of fitting hearing aids from a brand called Lexie: one group fitted the hearing aids themselves at home (the "Self Test and Fit" group), while the other group had them fitted by a hearing health professional (the "Professional Test and Fit" group). The trial measured things like how much difficulty people had hearing in everyday situations, how satisfied they were with their hearing aids, and how well they could hear speech in noisy conditions. The reported data shows that on the main outcome — a 24-question survey about hearing difficulty in daily life called the APHAB — the self-fit group scored 30.1 and the professionally fitted group scored 21.4 (on a scale of 1 to 99, where a lower number means less reported difficulty). On a separate satisfaction questionnaire called the IOI-HA (scored 7 to 35, where higher is more favourable), both groups reported the same score of 31. For a listening-in-noise test called the QuickSIN, the self-fit group showed a benefit score of 1.6 decibels and the professional-fit group showed 3.5 decibels. On another noise test (the Digits-in-Noise test), benefit scores were 0.50 decibels for the self-fit group and 0.13 decibels for the professional-fit group. The reported data also includes measurements taken inside the ear canal (called Real Ear Measurements) across several sound frequencies, which compared how closely the hearing aids matched a standard prescription target. The differences from that target ranged across both groups and frequencies, with figures varying from around −2.7 to 6.9 decibels in the self-fit group and 0.6 to 4.4 decibels in the professionally fitted group; the full breakdown by frequency was not labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04618315 · results posted 6 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 584 adults across three groups, each receiving a different approach to being fitted with hearing aids: one based on standard audiology best practice, one where the consumer made their own choices about the fitting, and one described as an efficient fitting process. The main thing being measured was self-reported hearing aid benefit at six weeks, using a questionnaire called the Profile of Hearing Aid Benefit — a 66-question survey where participants rated their hearing difficulties before and after using hearing aids, with a higher difference score indicating greater reported benefit. By the six-month follow-up point, roughly 424 of the original 584 participants had completed the study. The reported data shows that at the six-week mark, the average benefit scores on the Profile of Hearing Aid Benefit were very close across all three groups: 23.34 for the audiology best-practice group, 23.27 for the consumer-decides group, and 23.33 for the efficient-fitting group (all out of a possible 99 points). For a secondary measure — the Hearing Handicap Inventory for the Elderly, another self-reported questionnaire scored out of 100 — the reported benefit scores were 20.65, 21.83, and 19.15 respectively for the three groups. The reported data also shows that average daily hearing aid use differed somewhat between groups: 8.42 hours per day in the audiology best-practice group, 7.18 hours in the consumer-decides group, and 6.83 hours in the efficient-fitting group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04831281 · results posted 4 March 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04831281) enrolled 28 people across three groups: 9 received a placebo (a dummy treatment with no active ingredient), 9 received a 40 mg dose of ATH-1017, and 10 received a 70 mg dose of ATH-1017. ATH-1017 is an investigational drug being studied in relation to Alzheimer's disease. The trial was measuring two things: a standard cognitive test called the ADAS-Cog13 (where higher scores mean greater thinking difficulties, on a scale of 0 to 85), and a brain-activity measure called ERP P300 latency (which tracks how quickly the brain responds to sounds, where a longer delay suggests greater impairment). Not everyone completed the trial — 7 of 9 finished in the placebo group, 7 of 9 in the 40 mg group, and only 5 of 10 in the 70 mg group. The reported data shows that at the start of the trial (baseline), the three groups had somewhat different average scores on the cognitive test: the placebo group averaged 16.9 out of 85, the 40 mg group averaged 29.7, and the 70 mg group averaged 23.8. For the brain-response timing measure, the placebo group averaged 381.84 milliseconds, the 40 mg group averaged 373.19 milliseconds, and the 70 mg group averaged 367.84 milliseconds. The trial's main result was expressed as a combined score (called a Global Statistical Test or GST score) that blended both measures together. The reported data shows the placebo group's GST score was −0.222, the 40 mg ATH-1017 group scored 0.332, and the 70 mg group scored −0.036. In this scoring system, a negative value for the ATH-1017 groups (compared to placebo) would suggest a favourable response to the drug — the 70 mg group's result was slightly negative, while the 40 mg group's result was positive, meaning it did not point in the favourable direction relative to placebo. It is worth noting that the groups started the trial with notably different baseline cognitive scores, which can make comparisons between groups difficult to interpret, and the overall number of participants was very small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05476328 · results posted 13 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 participants, all of whom completed the study — none dropped out. The trial was looking at how well people could hear and repeat single-syllable words in a quiet environment. Specifically, it was comparing three different sound-coding strategies (ways that a hearing device processes sound): a standard approach called ACE, and two newer approaches called SPACE and OPAL-SPACE. The reported data shows that participants were scored on the percentage of single-syllable words they could correctly repeat back. For the ACE strategy, the reported average score was 51% of words repeated correctly. For the SPACE strategy, the reported average score was 51.25%, and for the OPAL-SPACE strategy, it was 48.50%. All three scores fell within a fairly narrow range of each other, between roughly 48% and 52% out of a possible score of 0% to 100%. It is worth noting that only 8 people took part, which is a very small number. No other outcome measure data was reported in the results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT05962814 · results posted 6 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 11 infants, with 10 completing the study and 1 not completing it. The trial was testing a device called EarGenie MVP, which uses a brain-scanning technique called fNIRS (functional near-infrared spectroscopy — a way of measuring brain activity through the scalp using light) to check whether sleeping babies can detect and tell apart different sounds. The researchers wanted to see whether the device could produce measurable, meaningful results in a real-world setting, comparing its output to results previously gathered with an established commercial device. The reported data shows that, for the primary outcome — measuring how many infants showed a clear brain response to sounds — 9 out of 10 infants showed a detectable response to a sound played at 65 dB SPL (roughly the volume of normal conversation), and 6 out of 10 showed a response that distinguished between two similar speech sounds ("Ba" versus "Ga"). The researchers had set a threshold beforehand: they would consider the device feasible if no more than 1 in 10 infants had an absent detection response, and no more than 3 in 10 had an absent discrimination response. The reported numbers show 1 infant had no detection response and 4 had no discrimination response. For the secondary outcome relating to adverse events (unwanted or harmful occurrences), the reported data shows that 0 out of 10 participants experienced any adverse events, though the precise breakdown of the remaining reported figures was not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03878875 · results posted 12 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 adults in total — 16 in a "High Noise Exposure" group and 16 in a "Low Noise Exposure" group. All 32 participants completed the study. The trial was measuring several aspects of hearing across two testing sessions (a planned third session was not completed). The measures included high-frequency hearing thresholds (how quietly a person can detect high-pitched sounds), inner ear responses called otoacoustic emissions (a way of testing how well tiny hair cells inside the ear are working), a reflex response in the middle ear, the ability to understand speech against background noise, and whether participants reported ringing in the ears (tinnitus). The reported data shows the following average figures across the two sessions. For high-frequency hearing thresholds (where higher numbers mean sounds need to be louder before they are heard), the High Noise group averaged 7.06 and then 7.94 dB HL across sessions, while the Low Noise group averaged 8.94 and then 12.19 dB HL. For inner ear hair cell responses, the High Noise group recorded 1.25 and 1.75 dB SPL, compared with −0.06 and −0.88 dB SPL in the Low Noise group; the related signal-to-noise ratio measure showed 12.94 and 13.13 dB for High Noise, versus 11.63 and 11.19 dB for Low Noise. The middle ear reflex was recorded at 88.91 and 91.25 dB SPL for the High Noise group and 88.44 and 90.31 dB SPL for the Low Noise group. For speech-in-noise understanding, the High Noise group scored 2.38 and then 1.38 dB, while the Low Noise group scored 2.94 and then 2.44 dB. Regarding tinnitus, in the first session 5 people in the High Noise group and 1 person in the Low Noise group reported existing tinnitus; in the second session, 5 people in the High Noise group and 7 people in the Low Noise group reported newly occurring or worsening tinnitus. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05076045 · results posted 5 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total, split into two groups of 16. It used a "crossover" design, meaning each participant tried both conditions — wearing Personal Sound Amplification Products (PSAPs, which are consumer hearing amplification devices) and wearing no device — with a one-week rest period in between. By the end of the trial, 28 participants completed both sessions. The trial was measuring how people performed on listening tasks in noisy environments, as well as tracking brain activity (using a technique called EEG, which records electrical signals from the scalp) while they listened. The reported data shows the following numbers across the main (primary) outcome measures. On a speech-in-noise test where participants identified words, those using PSAPs scored 85.2% correct answers on average, compared with 84.0% correct for those using no device. For how quickly participants responded (reaction time), the PSAP group averaged 528.7 milliseconds and the no-device group averaged 502.0 milliseconds. On a separate standardised listening-in-noise test (the QuickSIN, where a lower score indicates better performance), the PSAP group scored 3.6 and the no-device group scored 4.6. For the brain activity measures — which tracked a specific type of brain signal called "alpha power" across three noise levels (low, medium, and high) — the reported figures were very similar between the two groups, ranging from around -0.01 to -0.12 percentage points of power change in both conditions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05270876 · results posted 5 December 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, and all 20 completed the study — none dropped out. The trial was looking at two different methods of fitting (adjusting and setting up) cochlear implants or hearing devices, comparing a standard fitting method against a newer, novel fitting method. The main thing being measured was how well participants could correctly identify single-syllable words in a quiet environment under each method. The reported data shows that there was a difference of 3.8 percentage points in the scores between the two fitting methods, with the standard method and the novel method producing slightly different results on the word recognition test. To put that simply: on average, participants' scores for correctly identifying spoken words in quiet differed by 3.8 percentage points depending on which fitting method was used. No other outcome measures were included in the submitted results data, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT05286385 · results posted 5 August 2024
According to the results reported on ClinicalTrials.gov, this trial involved 10 participants, all of whom completed the study. The trial was comparing different versions of cochlear implant sound processors — specifically the CP1150 sound processor, the CP1150 with modified firmware (updated internal software), the CP1150 with a feature called "Forward Focus" (a directional microphone setting), and an older model called the CP1110. The main thing being measured was how well participants could correctly hear and repeat words in a quiet environment, using a standard word recognition test. The reported data shows that, for the primary outcome — speech understanding in quiet — participants scored an average of 13.82% correct words with the CP1150 using modified firmware, compared with 11.53% correct words with the standard CP1150. For the secondary outcomes, the CP1150 with Forward Focus was associated with a score of 11.24% correct words, again compared to 11.53% for the standard CP1150. When comparing the CP1150 to the older CP1110 processor, the reported scores were 11.53% and 11.97% correct words respectively. The reported data does not include further detail on whether these differences between scores were considered meaningful beyond the raw numbers provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05158296 · results posted 12 July 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05158296) enrolled a total of seven participants across three groups: two people received a lower dose of a medicine called ultevursen (60/60 micrograms), three people received a higher dose of ultevursen (180/60 micrograms), and two people received a sham procedure (a dummy treatment used for comparison). The trial was set up to measure changes in vision over time, looking at things like how clearly participants could read a standard eye chart, how well they could see in low light, and changes in a specific layer of the eye called the ellipsoid zone. The reported data shows that none of the seven participants completed the study — all seven are recorded as having not completed it. Because of this, no numerical results were reported for any of the outcome measures, including the primary measure (change in best-corrected visual acuity, which is essentially a standardised measure of how sharp a person's vision is) or any of the secondary measures. The data was not reported for any of these outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04754477 · results posted 10 June 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people who had received an active osseointegrated steady-state implant system — a type of surgically implanted hearing device anchored to the bone. Nineteen of the 20 participants completed the study, and one did not. The trial was tracking a range of things over the period following surgery, including any unwanted health events (called adverse events), any problems with the device itself (called device deficiencies), medications participants were taking at the same time, background information about participants' lives and healthcare use, and changes in hearing thresholds (the softest sounds a person can hear) measured by hearing tests. The reported data shows that across all participants, a total of 44 adverse events were recorded and broken down into categories by body system — with individual category counts including figures such as 16, 6, 5, 3, 3, 2, 1, 1, 1, and 1 events respectively. Separately, 19 device deficiencies were reported, all of which were classified within the same relationship category. Regarding medications taken during the study, small numbers of participants — 1 to 2 people in each category — were recorded as using concomitant (at the same time) medications. Background survey data captured things like employment and living situation for varying numbers of participants across different categories. The reported data for changes in hearing thresholds at 12 and 24 months after surgery was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03859648 · results posted 30 May 2024
According to the results reported on ClinicalTrials.gov, this trial looked at a bone-anchored hearing device called the BONEBRIDGE. Eight people started the study, six completed it, and two did not finish. The trial was measuring things like changes in hearing test scores, sound sensitivity with the device switched on, and whether any unwanted events related to the device occurred — all compared between the starting point (before the device was activated) and three months after activation. The reported data shows that one out of the eight participants experienced an adverse event (an unwanted occurrence) considered to be related to the device. For the main hearing test — understanding sentences against background noise (called the AZ Bio Sentence Score in Noise) — the reported average improvement from the starting point to three months after activation was 42.2%. A second hearing test measuring how well people understood individual words (the CNC Word Score) showed a reported average improvement of 38.3%. The reported data also shows that five participants had sound sensitivity levels (aided soundfield thresholds) that were the same or better than their starting point without the device; six participants performed the same or better on a speech-in-noise listening task; and seven participants had stable bone conduction (how well sound travels through the bones of the skull) readings compared to before their operation. It is worth noting that this was a very small study — only eight people took part — and the data was not reported separately for the two participants who did not complete the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05265260 · results posted 5 April 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 adults who were already using a Nucleus cochlear implant (a device surgically placed to help people with severe hearing loss). All 32 participants completed the study, with no one dropping out. The trial was measuring how well participants could recognise spoken sentences in a quiet environment, using a French-language test called the MBAA2. Based on their scores, participants were placed into one of two groups: "good performers" (those who correctly identified 90 or more sentences out of 100) and "poor performers" (those who correctly identified fewer than 90 out of 100). The reported data shows that, out of the 32 participants, 13 were classified as good performers — meaning they scored 90 or above on the sentence recognition test — while 19 were classified as poor performers, meaning they scored below 90 out of 100. No other outcome measures appear to have been reported in the submitted data, so further details about any additional measurements are not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05374421 · results posted 12 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05374421) looked at whether the Erchonia® THL™ laser device had any effect on tinnitus — a condition where people experience ringing or other noises in their ears — compared to a placebo (inactive/fake) laser. A total of 15 people started the trial: 8 were assigned to the active laser group and 7 to the placebo laser group. Of those, only 8 people finished the trial (5 in the active group and 3 in the placebo group), meaning a notable number of participants — 3 from the active group and 4 from the placebo group — did not complete it. The reported data shows that the main thing being measured was the change in a tinnitus questionnaire score called the Tinnitus Functional Index (TFI). This is a self-reported questionnaire scored from 0 to 100, where a higher score reflects a greater impact of tinnitus on daily life, and a lower (more negative) change from the starting score means the impact appeared to lessen over the course of the trial. According to the results reported on ClinicalTrials.gov, the active laser group's average TFI score changed by −8.96 points from the start to the end of the trial, while the placebo group's average score changed by −2.8 points. Both groups showed a decrease in their scores, meaning both reported some reduction in how much tinnitus was affecting their everyday lives, based on the questionnaire. It is worth noting that this was a very small trial with only 15 participants at the start and just 8 who completed it, which means these numbers should be interpreted with a great deal of caution. The reported data does not include information on whether the difference between the two groups was considered statistically meaningful, and no safety or side-effect data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04987021 · results posted 21 February 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants, all of whom completed the study with none dropping out. The trial involved a single group of participants who used a smartphone app called the Nucleus Smart App, which included a feature called "Remote Assist Custom Sound Pro 6.3." The study was measuring how easy the app was to use — specifically, whether participants could complete certain key tasks on their first try without any help. The reported data shows that the trial used a usability rating scale running from 1 to 5, where a score of 1 meant a person was unable to complete a task at all, and a score of 5 meant they completed it successfully on their very first attempt with no assistance. The primary outcome being tracked was how many of the 15 participants achieved that top score of 5 — meaning they completed the key tasks first go. According to the results reported on ClinicalTrials.gov, 13 out of 15 participants achieved this top score using the final version of the app. No secondary outcome measures were included in the submitted results data. It is worth noting that this trial had a small number of participants and was focused on usability — that is, ease of use — rather than medical or health outcomes, so the numbers reflect how people interacted with the app's interface. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03533686 · results posted 8 August 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 66 participants across six groups. The groups included adults with hearing loss on one side only (single-sided deafness), adults with a type of hearing loss caused by sound not passing through the ear properly (conductive hearing loss), and children with either one-sided or two-sided conductive hearing loss. The trial was comparing two types of bone-conduction hearing devices: a surgically implanted device (called BAHA, which attaches to a small titanium fitting in the skull) and a non-surgical stick-on device called Adhear. The main thing being measured was how quietly a sound could be heard while wearing each device — known as an "aided hearing threshold" — along with some measures of how well people could understand speech in noisy settings. The reported data shows the following for adults with single-sided deafness on Day 1: across six sound frequencies tested, the BAHA implant group's aided hearing thresholds ranged from about 20 to 36 hertz, while the Adhear group's ranged from about 30 to 51 hertz (lower numbers mean softer sounds could be heard). For adults with conductive hearing loss on Day 1, the BAHA group's thresholds ranged from roughly 13 to 38 hertz, and the Adhear group's ranged from roughly 20 to 55 hertz. Similar patterns were reported at Day 14 across both groups and device types. For children and young people using bone-conduction devices, thresholds reported ranged from 10 to 30 hertz depending on the group and device. For the secondary measure — understanding speech in background noise — three scores were reported for the single-sided deafness group on Day 1, with the BAHA implant group recording values of approximately 1.75, 2.0, and −2.31 decibels, and the Adhear group recording approximately 1.81, 5.75, and −4.31 decibels. No data was reported for several other secondary outcomes in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05165121 · results posted 6 July 2023
According to the results reported on ClinicalTrials.gov, this trial involved three groups of participants. Twenty people took part in a "Human Factors" study looking at how easily people could use the hearing aids. Thirty-six people were enrolled in a "Self-Fit" group (where participants fitted the hearing aids themselves) and 35 in a "Professional Fit" group (where a hearing professional fitted the devices). By the end of the study, 20 Human Factors participants, 32 Self-Fit participants, and 32 Professional Fit participants had completed the trial. The trial was measuring two main things: how well participants in the Self-Fit and Professional Fit groups reported changes in their hearing experience after one month (using two questionnaire tools — the APHAB and the SSQ 12), and whether Human Factors participants were able to operate the hearing aids with or without guidance. The reported data shows that all 32 participants in both the Self-Fit and Professional Fit groups were counted across the hearing questionnaire measures (APHAB and SSQ 12, including Part B of the SSQ 12) at the one-month mark. However, the actual scores or averages from those questionnaires were not reported in the structured data submitted to ClinicalTrials.gov, so it is not possible to describe what those numbers showed. For the Human Factors group, the reported data shows that 100% of participants were recorded as being able to use the hearing aids — either with or without guidance from the provided manual. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05274165 · results posted 12 June 2023
According to the results reported on ClinicalTrials.gov, this trial involved 25 participants split across two groups — 12 people in Group A and 13 people in Group B. The trial was measuring something called the "trial to success rate," which tracked how many participants said they intended to buy the device being studied after using it during the trial period. By the end of the study, 9 people in Group A and 10 people in Group B completed the trial, with 3 people in each group not finishing. The reported data shows that when it came to the main outcome — the number of participants who expressed an intention to purchase the device — 2 people in Group A said they intended to buy it, while no participants in Group B expressed that intention. The study organisers noted that no statistical analysis (a process used to mathematically compare results between groups) was performed on this outcome measure, meaning the numbers are presented as a straight count only. It is worth noting that the data submitted to ClinicalTrials.gov for this trial includes only this one outcome measure, with no secondary outcomes reported. If there were other things being measured during the trial, those results were not included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05198713 · results posted 6 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT05198713) enrolled 15 participants, all in a single experimental group, and all 15 completed the study with no drop-outs. The trial was measuring how well participants could understand spoken words — both in a quiet environment and in a noisy one — under two conditions: without a hearing device (unaided) and with one (aided). The reported data shows that for understanding words in quiet, participants correctly repeated an average of 92.3% of words in the unaided condition and 90.6% in the aided condition. For understanding words in noise, the trial used a measure called signal-to-noise ratio — this describes the difference in volume between the speech and the background noise at the point where a person can correctly repeat half the words spoken. In this test, a more negative number means the person can still understand speech even when it is quieter than the surrounding noise, which is considered better performance. The reported data shows an average score of −9.83 in the unaided condition and −5.87 in the aided condition. No additional breakdown of these figures was reported in the submitted data. It is worth noting that because there was only one group in this study and no comparison group, these numbers describe what was measured in that single group alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04120116 · results posted 27 April 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04120116) tested an investigational ear injection called FX-322 in people with sensorineural hearing loss — a type of hearing loss caused by damage to the inner ear. A total of 95 people took part across four groups: one group received a single dose of FX-322 followed by three dummy (placebo) injections; a second group received two doses of FX-322 and two placebo injections; a third group received four doses of FX-322; and a fourth group received four placebo injections. The trial measured several things, including how well participants could recognise words in quiet and in noisy conditions, their overall hearing thresholds (how loud a sound needs to be before someone can hear it), and any abnormalities detected in ear examinations. The reported data shows that for the main word recognition test (hearing words in quiet), the percentage of participants whose scores improved beyond what would normally be expected by chance was 23.8% in the single-dose FX-322 group, 16.7% in the two-dose group, 15.8% in the four-dose group, and 41.2% in the placebo group. For the words-in-noise test, the reported average change in words recognised was 2.58% for the single-dose group, 3.33% for the two-dose group, 1.80% for the four-dose group, and 3.61% for the placebo group. Average hearing threshold scores (measured in decibels, where a higher number means sounds need to be louder to be heard) were broadly similar across all groups, ranging from approximately 52 to 55 decibels. Regarding ear examination findings, the reported data shows small numbers of ears with detected changes in ear canal or eardrum appearance across some groups, and similarly small numbers with changes in middle ear measurements. The reported data also shows that 16 participants in the single-dose FX-322 group, 16 in the two-dose group, and 19 in the four-dose group experienced treatment-related side effects, compared with 12 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04829214 · results posted 6 January 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04829214) enrolled 153 people with tinnitus (a persistent ringing or noise in the ears) — 77 received a treatment called OTO-313 and 76 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether OTO-313 reduced the impact of tinnitus on participants' daily lives, using a standard tinnitus questionnaire called the Tinnitus Functional Index (TFI), as well as daily ratings of how loud and how annoying the tinnitus was, and participants' own overall impression of change. The reported data shows that for the main measure — the proportion of people whose TFI score improved by at least 13 points at both week 4 and week 8 — 20 participants in the OTO-313 group and 27 participants in the placebo group met this threshold. For the secondary measures at week 8, the OTO-313 group reported an average decrease of 0.67 points (out of 10) in daily tinnitus loudness, compared to a decrease of 0.90 points in the placebo group. For daily tinnitus annoyance, the OTO-313 group reported a decrease of 0.73 points, compared to 1.11 points in the placebo group. Participants' own overall rating of change in their tinnitus averaged 0.32 (on a scale from –3 to +3) in the OTO-313 group and 0.36 in the placebo group. The reported data also shows that, at the final check-up visit (week 16), no participants in either group had an eardrum perforation that had not healed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01975571 · results posted 8 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT01975571) involved three groups of participants using cochlear implants: 15 adults, 5 children and adolescents in one group (referred to as "L24"), and a third group of children and adolescents (referred to as "S12") in which no participants were enrolled. In total, 20 people started the trial — 14 adults and 3 children/adolescents completed it, while 1 adult and 2 children/adolescents did not finish. The trial was measuring changes in word and sentence understanding, as well as the ability to tell which direction a sound was coming from, before and after receiving a cochlear implant. The reported data shows that for the main measure — understanding single words read aloud (called the CNC word test, scored as a percentage of words correctly identified) — adults started at around 28% correct before the implant, and the reported scores at various points after the implant ranged up to around 71% correct. The children and adolescents (L24 group) started at 34% correct before the implant, with post-implant scores reported ranging between approximately 61% and 68% correct. For sound localisation — that is, being able to judge which direction a sound was coming from — scores were measured as average error in degrees (a lower number means less error). The reported data shows adults had an average error of 23 degrees before the implant and 34 degrees at one follow-up point, while the L24 children's group had 18 degrees before and 26 degrees at one follow-up point. For sentence understanding in background noise (adults only), pre-implant scores were reported at around 15% correct, rising to around 51% correct at the last reported follow-up point. No localization or sentence-in-noise data was reported for the S12 children's group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04237207 · results posted 13 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04237207) involved 22 people who use cochlear implants — 10 in a group described as "Electric Only" (meaning they rely entirely on the implant for sound) and 12 in a group described as having "Aidable Residual Hearing" (meaning they had some natural hearing remaining that could be assisted). All 22 participants completed the study. The trial was comparing word recognition scores between a new sound processor and an already-approved processor, to see whether scores with the new device were similar or different. The reported data shows the following for the main measure — understanding sentences in a quiet room, scored from 0% to 100% correct words. With the already-approved processor, the Electric Only group scored an average of 87.30% and the Aidable Residual Hearing group scored 88.09%. With the new processor, those figures were 88.31% and 89.39% respectively. For the secondary measure of understanding speech in a noisy environment, the reported data shows the Electric Only group scored 52.95% with the new processor compared to 76.37% with the approved processor, while the Aidable Residual Hearing group scored 66.04% with the new processor compared to 84.98% with the approved processor. A further secondary measure compared the new processor's noise score when using an automatic sound-adjusting feature ("AutoSense") versus a basic setting with no automatic adjustment ("Omnidirectional"): the Omnidirectional scores were lower — 42.93% for the Electric Only group and 51.37% for the Aidable Residual Hearing group — compared to the AutoSense scores of 76.37% and 84.98% respectively. It is worth noting that the data as submitted does not include information about how meaningful these differences are in a statistical sense, and no quality-of-life or side-effect data was reported in this results submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04231396 · results posted 14 January 2022
According to the results reported on ClinicalTrials.gov, this trial involved 27 adults who use hearing aids or cochlear implants. All 27 participants completed the study. The trial was measuring whether using an audiobook-based app as a listening training program over 12 weeks was associated with changes in how well participants could understand speech in noisy environments. It also looked at how consistently participants stuck to their weekly app usage goals, and whether they said they would buy or recommend the app at the end of the study. The reported data shows that the main outcome measured participants' scores on a speech-in-noise hearing test (called the BKB-SIN) during weeks 7 to 12 of the program. Scores on this test reflect how much background noise a person needs removed to understand speech — lower scores indicate better listening in noise. The six weekly scores reported were 5.978, 5.889, 5.757, 5.600, 5.398, and 5.088 (in decibel units), showing a pattern of gradually decreasing numbers across those weeks. For the secondary outcomes, the reported data shows that across five separate weekly tracking points, participants met their app usage goals at rates of approximately 92.75%, 96.67%, 95.45%, 94.20%, and 98.15%. Separately, when asked at the end of the 12 weeks whether they would buy or recommend the app to someone who recently received a hearing aid or cochlear implant, 77% of participants answered positively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02004353 · results posted 8 November 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,518 people who received a Cochlear® hearing implant. The study tracked participants over time to measure two things: how their hearing ability changed (using a questionnaire called the Speech Spatial Hearing Qualities scale, scored from 0 to 10, where 0 means "cannot hear at all" and 10 means "hear perfectly"), and how their general quality of life changed (using a questionnaire called the Health Utility Index, scored from 0 to 1, where 0 represents death and 1 represents perfect health). Of the 1,518 people who started, 184 completed the trial and 1,334 did not complete it. The reported data shows that, on the hearing questionnaire, participants' scores were on average 2.73 points higher than their starting score at the one-year mark, 2.95 points higher at two years, and 2.74 points higher at three years. A positive number here means scores moved in the direction of better hearing on that scale. For the quality-of-life questionnaire, the reported data shows average score changes of +0.166 at one year, +0.175 at two years, and +0.123 at three years compared to each participant's starting score — with positive numbers indicating movement toward better health on that scale. It is worth noting that the large number of participants who did not complete the trial (1,334 out of 1,518) means these reported figures are based on a relatively small proportion of those who started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03134989 · results posted 24 September 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 adults who had received one of several cochlear implant models (the CI522, CI532, CI622, CI632, or Hybrid-L24 devices). All 80 participants completed the study. The trial was measuring changes in low-frequency hearing — that is, the ability to hear lower-pitched sounds — before and after cochlear implant surgery. It also looked at whether a signal recorded from inside the ear during surgery (called a "cochlear microphonic" response, a tiny electrical signal produced by the inner ear) could predict how much a person's low-frequency hearing might change after the implant was placed. The reported data shows that, on average, participants' low-frequency hearing thresholds (a measure of how loud a sound needs to be before someone can hear it, expressed in decibels or "dB") changed by about 26.9 dB when measured 4–6 weeks after surgery compared to before surgery. When the same comparison was made at 3 months after the implant was switched on, the reported average change was approximately 31.52 dB. A higher number here means the threshold shifted further from the pre-surgery measurement. The trial also looked at whether the point during surgery at which the cochlear microphonic signal was first detected was related to a person's pre-surgery high-frequency hearing. The reported data shows a Pearson correlation coefficient of 0.78 — a correlation coefficient is a number between –1 and 1 that indicates how closely two things move together, with a value closer to 1 suggesting a stronger relationship — between these two measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04147442 · results posted 16 September 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants, all of whom completed the study with no dropouts. The trial was comparing two hearing aid program settings for listening to music: a "fine-tuned" (optimised) music program and a standard music program. Participants tried both programs and were asked about their preferences and how well they could perceive different elements of sound, such as pitch, loudness, and the duration of musical notes. The reported data shows that when asked which program they preferred, 14 out of 20 participants chose the fine-tuned music program, 3 chose the standard program, and 3 reported no preference. For the sound quality ratings (scored on a 1-to-5 scale, where 5 is best), the reported average scores were 0.66 and 0.69 — though the data as submitted does not clearly separate which score belongs to which program individually. For the listening tests, lower scores indicated it was easier to notice differences between musical sounds. The fine-tuned program returned scores of 1.4 Hz (pitch), 1.5 dB (loudness), and 31 milliseconds (note duration). The standard program scored 1.8 Hz, 1.7 dB, and 39 milliseconds. Without hearing aids at all, the scores were 1.9 Hz, 1.9 dB, and 35 milliseconds. The reported data also shows that zero participants experienced a device-related adverse event, though this figure alone does not allow any conclusions about safety to be drawn. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04041700 · results posted 18 August 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 29 adults who received the Osia 2 System, a type of implanted hearing device. Twenty-seven participants completed the study. The trial was set up to measure changes in hearing performance after the device was fitted, comparing how participants heard with the device switched on versus their unaided hearing before surgery. The main measurements taken were hearing thresholds (the softest sounds a person could detect) and the ability to understand speech when background noise was present. These were assessed at four weeks, three months, and six months after surgery. The reported data shows that, at the primary three-month time point, participants' average hearing threshold — a measure of how soft a sound needs to be before someone can just hear it — changed by −27.3 dB HL (decibels Hearing Level) when wearing the device compared to their unaided hearing before surgery. A negative number here means sounds became detectable at lower volumes with the device on. For understanding speech in noise, the reported change was −9.10 dB SNR (decibels Signal-to-Noise Ratio); again, a negative number in this context means less background noise was needed relative to the speech signal for participants to understand half of what was said. The reported data shows similar patterns at the four-week and six-month check-ins, with threshold changes of −25.6 dB HL and −28.4 dB HL respectively, and speech-in-noise changes of −8.76 and −8.84 dB SNR. For the secondary measures, the reported data shows that word recognition scores in quiet (how many words participants could correctly identify) ranged from approximately 24% at the quietest sound level tested (50 dB SPL) up to around 63% at the loudest level tested (80 dB SPL) across the three follow-up time points. Hearing threshold changes across a broader range of sound frequencies were also reported at each time point, with the figures varying by frequency. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04004260 · results posted 11 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04004260) enrolled 158 people in total — 79 in an experimental group and 79 in a weekly check-in control group. The trial was measuring tinnitus distress (the ringing or noise in the ears that bothers people) and several related areas including thought patterns around tinnitus, depression, anxiety, sleep problems, and overall quality of life. Participants filled in questionnaires at multiple points during the study. Not everyone finished — 37 people in the experimental group and 47 in the control group completed the study. The reported data shows that both groups started with similar tinnitus distress scores (around 54 out of 100, where higher means more distress). By the end of the study, the experimental group's reported score had dropped to about 25, while the control group's score had dropped to about 33. For anxiety (scored out of 21), both groups started similarly (around 6) and both ended at roughly similar points (about 4 for the experimental group and 5 for the control group). For depression (scored out of 27), the experimental group started at about 5.5 and ended at about 3.2, while the control group started at about 5.4 and ended at about 3.7. For sleep problems (scored out of 28), the experimental group went from about 10 down to about 5, while the control group went from about 10 down to about 6. For overall quality of life (scored out of 100, where higher is better), both groups started around 76–78 and finished around 78–81. The reported data shows that thought pattern scores around tinnitus were not clearly reported across all time points in a way that allows straightforward comparison, so caution is needed in interpreting those numbers. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02665975 · results posted 14 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 92 adults with tinnitus (a ringing or noise in the ears) — 46 in each group. One group received an internet-based cognitive behavioural therapy program (a structured talking-therapy delivered online, often called iCBT), while the other received standard face-to-face clinical tinnitus care. By the end of the study, 37 people in each group had completed all measurements, with 9 in each group not finishing. The trial was measuring how much tinnitus bothered participants, as well as related areas such as quality of life, concentration and memory difficulties, and signs of depression and anxiety. The reported data shows that for the main measure — the Tinnitus Functional Index (a 0–100 scale where higher scores mean tinnitus is more bothersome) — the iCBT group scored an average of 22.85 at the end of the trial, compared with 32.51 for the face-to-face group. Both groups started at similar levels (around 55 out of 100). On a second tinnitus measure, the Tinnitus Handicap Inventory (also 0–100, higher is worse), end scores were 17.78 for the iCBT group and 27.11 for the face-to-face group, again from similar starting points in the mid-to-high 40s. For the other measures — life satisfaction, concentration difficulties, signs of depression, and anxiety — the reported data shows the two groups had broadly similar scores at both the start and end of the study, with relatively small differences between them across all of those scales. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01649869 · results posted 2 June 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total — 18 in the placebo group and 17 in the active treatment group. Most participants completed the trial (16 in each group). The trial was measuring changes in hearing across both ears over time, with a specialist audiologist — who did not know which treatment each person had received — classifying hearing for each ear as normal, mild, moderate, or severe hearing loss at the start of the trial and again later. The reported data shows the following for the main (primary) outcome, which looked at individual ears: in the placebo group, 27 ears stayed the same or showed improved hearing, while 1 ear worsened; in the active treatment group, 20 ears stayed the same or improved, while 6 ears worsened. For several of the secondary outcomes — which looked at each person's better-hearing ear — the reported data shows that in one measure comparing improvement versus other outcomes at 6 months, 0 participants in either group were recorded as having improved hearing. In a measure looking at worsening or no change (where hearing was already abnormal), 6 placebo participants and 6 active-treatment participants fell into that category. When looking specifically at worsening alone, 0 placebo participants and 3 active-treatment participants were recorded as worse, compared to 15 and 9 respectively in the "other" category. For the final secondary measure covering all individual ears at 6 months, 0 ears in either group showed improvement, while 28 ears (placebo) and 26 ears (active) fell into the "other" category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03897634 · results posted 28 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 22 adults who were already experienced hearing aid users. All 22 participants completed the study — none dropped out. The trial was measuring changes in how participants rated their own hearing experiences in everyday situations, using two self-report questionnaires, as well as how well they could repeat words from sentences played against background noise. The reported data shows the following. On the main outcome measure — a questionnaire called the APHAB, where a lower score means fewer reported problems — participants' scores changed from their starting point by an average of 7.64 percentage points overall. Looking at the four individual categories: the "ease of communication" category changed by 12.5 points, "reverberation" (echoing sounds) changed by 4.8 points, "background noise" changed by 6.3 points, and "aversiveness" (reactions to loud or unpleasant sounds) changed by minus 2.6 points (meaning slightly more problems reported in that category). The trial's own benchmark for a meaningful change in the first three categories was 22 points, and 31 points for the aversiveness category. For the second questionnaire — the SSQ, scored from 0 to 10 where higher is better — the overall score changed by 1.7 points, with a 0.6-point change in the speech subscale and a 1.1-point change in the spatial hearing subscale. The trial noted that a change of 2 points is considered a moderate effect on this scale. For the sentence recognition test in background noise, the reported data shows scores of 60.0% correct in one noise condition and 82.7% correct in another, though the data as submitted does not specify which noise level each figure corresponds to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02852330 · results posted 25 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people, and all 20 completed the study — none dropped out. The trial involved a single group of participants who received a cochlear implant (a device surgically placed in the ear to help with hearing loss). The study was measuring something called "voltage tomography" — a technique that uses electrical signals to gather information about how the implant's electrode array sits inside the ear after it is inserted. Researchers were also looking for any instances of what is called a "tip foldover," which is when the tip of the electrode array bends back on itself during insertion rather than sitting correctly. The reported data shows that out of 20 participants, measurements were recorded for 19, with 1 participant noted separately across two different measurement categories. This pattern appears twice in the reported figures (19 and 1, repeated). The data was described as being gathered for "retrospective analysis," meaning it was collected to build a reference set of measurements for future comparison purposes. No further breakdown of what the voltage tomography readings showed in detail was included in the submitted results data. It is worth noting that because this trial was primarily collecting reference data rather than testing one treatment against another, the reported numbers reflect how many people had measurements taken rather than a treatment outcome in the traditional sense. Any details beyond the participant counts were not reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02671032 · results posted 20 November 2020
According to the results reported on ClinicalTrials.gov, this trial involved 12 participants who all received a Nucleus CI532 cochlear implant (a surgically placed hearing device). All 12 participants completed the study — none dropped out. The trial was measuring several things: how well participants could hear tones at different pitches (using a standard hearing test called a pure tone audiogram), how well they could understand words and sentences in background noise, how many unwanted medical or device-related events occurred, and how participants felt about their own hearing using two questionnaires. The reported data shows that, on the speech understanding tests, scores (measured as the percentage of words heard correctly) varied across participants and time points, with values ranging from around 10% correct up to about 82% correct at different stages of the study. For the hearing tone tests, the data was reported as the number of participants falling into different hearing categories at various time points. Regarding unwanted events, the reported data shows that between 1 and 2 adverse events (unexpected or unwanted occurrences) were recorded at each time point across the study. The reported data also shows results from two self-reported questionnaires. On the Speech, Spatial and Qualities of Hearing Scale (SSQ) — where 0 means "not at all" and 10 means "perfectly" — scores ranged from around 3.9 to 6.5 across different aspects of hearing and time points. On the Glasgow Benefit Inventory (GBI) — a questionnaire scored from -100 to +100, where higher numbers suggest greater self-reported benefit — the reported scores ranged from approximately 15 to 67 across different categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01854879 · results posted 4 November 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01854879) involved 97 participants, all of whom used a cochlear implant sound processor called the Nucleus 6. Of the 97 who started, 92 completed the study, and 5 did not finish. The trial was measuring how well participants could understand speech in a noisy environment — specifically, how many words they could correctly hear from sentences played in front of them while background noise was played to the side of their implanted ear. The reported data shows that the primary outcome was the percentage of words that participants correctly identified in this speech-in-noise test. The test used several built-in sound processing features of the device, including tools designed to adjust volume automatically, reduce background noise, manage wind noise, and analyse the listening environment. According to the results reported on ClinicalTrials.gov, participants scored an average of 72.1% of words correct under these conditions. No other outcome measures appear to have been reported in the submitted data. It is worth noting that this trial had only one group — there was no comparison group — so the reported figure of 72.1% reflects performance with the device's features active, but the submitted data does not include a comparison to a different setting or a control condition. Any additional detail about how individual features contributed to this result was not reported in the structured data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03304106 · results posted 29 October 2020
According to the results reported on ClinicalTrials.gov, this trial involved two groups of people who had received a cochlear implant (a surgically implanted hearing device). The first group had 44 newly implanted recipients, and the second group had 58 people who already had an existing cochlear implant. In total, 31 people in the first group and 56 in the second group completed the study. The trial was measuring how well participants could recognise single spoken words in a quiet environment, using a standardised test called the CNC word test, where results are given as a percentage of words correctly identified. The reported data shows that for the newly implanted group, the average word recognition score before their cochlear implant procedure was 13.9% correct, and after six months of using the implant that score was reported as 60.2% correct — a reported change of around 46 percentage points. For the existing cochlear implant group, the reported score at the first visit was 60.1% correct, and after one month it was reported as 59.1% correct — a difference of approximately one percentage point. These figures simply describe what was measured and recorded at those time points; they do not on their own tell us why the scores changed or whether any change was due to the device alone. It is worth noting that the structured data submitted to ClinicalTrials.gov only reported results for this one primary outcome measure — no secondary outcome measure results were included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01892007 · results posted 1 October 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 57 adults in total — 27 in one group and 30 in another — and all participants completed the study with no dropouts reported. The trial was comparing two versions of a computerised brain-training program called Cogmed RM: one version that automatically adjusted its difficulty as the participant progressed (the "adaptive" group), and one version that did not change in difficulty and acted as a comparison or placebo group. The study measured several things related to memory, attention, and the ability to understand speech, particularly in noisy situations. The reported data shows a range of scores across the two groups at different time points. For the main outcome — a task where participants had to spot three-letter words hidden in a sequence of letters — the adaptive group scored around 8.5 out of 10 at the start, and scores across both groups hovered in a similar range throughout the study. For the secondary measures, in a sentence-understanding task in background noise, both groups scored roughly in the 15–33% range for correct words repeated. In a test of listening to one voice while ignoring another, scores for both groups sat between approximately −3.9 and −6.8 decibels (where a lower number reflects better performance on that test). Memory for number sequences, sound-discrimination ability, and listening-attention reaction times were also measured, with the reported numbers showing some variation between groups and across time points. Where certain time-point comparisons have incomplete data for one group, those figures were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02826694 · results posted 8 July 2020
According to the results reported on ClinicalTrials.gov, a total of 106 newborns took part in this trial — 61 healthy ("well") infants and 45 infants who had already received a diagnosis through standard newborn screening. The trial was looking at two main things: how parents decided whether to take part after using an online decision-support tool, and how well a type of detailed genetic test called whole exome sequencing (which reads a large portion of a baby's genetic code) could identify genetic conditions in newborns. The reported data shows that, after completing the online decision aid, 120 parents in the healthy infant group and 57 in the diagnosed infant group chose to go ahead with sequencing, while 25 in the healthy group and 2 in the diagnosed group chose not to. Regarding the genetic testing results, among the 45 diagnosed infants, 28 were found to have genetic variants considered likely to explain their condition, 17 had variants that could not be clearly confirmed or ruled out, 5 had variants in genes not directly related to their newborn screening result, and 15 had no relevant variants detected. Among the 61 healthy infants, 1 was found to have a variant in the category of genes examined, while the rest had none detected in that category. The reported data also includes a measure of how parents felt after receiving their child's results, using a scoring tool designed to capture worries and distress (scored from 0, meaning "never," to 5, meaning "often"). Parents who had the option to receive extra genetic information about their child scored 2.3 at two weeks after receiving results and 2.5 at three months after, while parents in the group who were not offered extra information scored 1.7 and 1.5 at the same time points. These scores reflect what was recorded and reported — no conclusions about the meaning of these differences should be drawn without speaking to a health professional. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03294681 · results posted 29 June 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 153 people who had received cochlear implants (devices surgically placed in the ear to assist with hearing). Of those, 152 completed the study and one did not. The trial was measuring how well a specific test — called a transimpedance measurement, which involves passing a small signal between electrodes inside the implant — could detect a problem called "electrode fold-over." A fold-over is when one of the implant's electrodes bends back on itself during surgery, which is something surgeons want to identify quickly. The test was done using a device called Custom Sound EP 5 and took about one minute to complete during the operation. The reported data shows one outcome was measured and reported: "specificity." In plain terms, specificity is a way of describing how often a test correctly identifies that a problem is *not* present — in other words, how rarely it gives a false alarm. The reported data shows that, among 148 ears where imaging confirmed there was no electrode fold-over, the test correctly identified them as fold-over-free 98.6% of the time. No other outcome measures were included in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03086135 · results posted 5 February 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 51 people who received a bone-conduction hearing device called the OSIA system. Of those, 48 people completed the study and 3 did not. The trial was measuring how participants' hearing changed after receiving the implanted device, comparing their hearing without the device (before surgery) to their hearing while using the device at several points in time: 4 weeks, 3 months, 6 months, and 12 months after surgery. The reported data shows two main (primary) outcomes measured at 3 months. The first looked at the softest sounds participants could detect across four key pitches — a measure called Pure Tone Average, or PTA4 (think of it as an overall snapshot of how quietly someone can hear). The reported difference between unaided and aided hearing was −25.8 decibels (dB), meaning participants could detect softer sounds when using the device than without it; in this type of test, a more negative number reflects a greater change. The second primary outcome measured how well participants could follow speech in a noisy environment. This was captured as a Speech-to-Noise Ratio (SNR) — roughly, how loud speech needed to be compared to background noise for someone to understand half of it. The reported change was −13.3 SNR units, where a more negative number means speech did not need to be as loud relative to the noise. The secondary outcomes showed similar patterns at 4 weeks (−24.9 dB PTA4), 6 months (−27.9 dB), and 12 months (−30.4 dB). For understanding words in quiet, the reported changes in the percentage of words correctly heard ranged from roughly +29 to +68 percentage points across different sound levels and time points, with positive numbers indicating more words were understood with the device than without it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT03848910 · results posted 5 February 2020
According to the results reported on ClinicalTrials.gov, this trial involved 11 participants, all of whom completed the study. The trial was testing an investigational hearing sound processor by comparing it to the participants' existing (precursor) sound processor. Participants wore each device and completed a series of hearing tests and questionnaires at the start of the study and again after six weeks with the investigational device. The reported data shows the following changes when participants switched from their old processor to the investigational device. On the APHAB questionnaire — which measures everyday listening difficulties on a scale of 0–100%, where lower scores mean fewer problems — the reported average change across the overall score and its sub-categories ranged from approximately 3.5 to 7.0 points, with positive values in this context indicating a reduction in reported difficulties. On the SSQ questionnaire — which measures speech, spatial, and general hearing experiences on a 0–10 scale, where higher scores mean better hearing — the reported overall change was 1.0 point, with sub-category changes ranging from approximately 0.06 to 0.96 points. For the hearing threshold tests (how soft a sound a person can detect), the average change across four key frequencies was −2.5 decibels, and changes at individual frequencies ranged from roughly −0.9 to −6.4 decibels, where a negative number indicates the ability to detect softer sounds. The speech-in-noise test — measuring the balance between speech and background noise needed to understand sentences — showed a reported change of −1.3 and −1.2 in two conditions, where a more negative number indicates better understanding in noise. Satisfaction questionnaire data (QUEST) was also collected, though the figures reported represent how many participants nominated certain device features (such as adjustments and safety) as most important to them, rather than a simple overall score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03086018 · results posted 6 November 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 adults who wore a new (experimental) hearing aid — described as a successor to a device called Juna. All 30 participants completed the first stage of testing (field testing), and 28 of the 30 completed the final stage. The trial was measuring several things: how well people could understand speech in noisy situations, how participants felt about the hearing aid in everyday life, how well they could handle and use the device, and how many unexpected device-related events occurred. The reported data shows the following numbers. For the main (primary) outcome — understanding speech in noise — scores were recorded in three conditions: without any hearing aid, with a current device, and with the new device. The scores were −1.25, −3.89, and −5.22 decibels (dB) respectively (a lower number on this particular scale indicates picking up more words correctly at a harder listening level). For the quality-of-life questionnaire (APHAB), the reported data shows scores of 37.38, 44.29, 42.08, 40.30 on the positive subscales (where higher numbers indicate better self-reported performance), and −17.63 on the aversiveness subscale (a negative scale where a higher number indicates worse performance). For word recognition with a specific new feature turned on and off, at two different noise levels, the reported scores ranged from 73.5% to 88.1% of words correct. For device handling and usability, 97% of tasks were completed without any help from the clinician. Four device-related unexpected events were reported across the whole trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02099786 · results posted 9 October 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 veterans across two groups: 24 in the COMP-VA group (a specialised monitoring programme) and 23 receiving usual care. The trial was measuring hearing changes over time, access to hearing rehabilitation services, deaths within one year, and hearing-related quality of life. Not all participants completed the study — by the end, 21 remained in the COMP-VA group and 15 in the usual care group. The reported data shows the following numbers across the four primary outcomes. For hearing shifts (measurable changes in hearing ability), 15 out of the COMP-VA participants and 8 out of the usual care participants recorded a significant hearing shift by the final assessment. For access to audiology rehabilitation services — such as receiving or adjusting hearing aids — 12 participants in each group accessed these services. Regarding deaths within one year of joining the trial, 2 were recorded in the COMP-VA group and 4 in the usual care group. Finally, hearing-related quality of life was measured using a questionnaire scored from 0 to 100, where a higher number means greater difficulty — the COMP-VA group averaged a score of 20.8, and the usual care group averaged 23.2. It is worth noting that this was a relatively small trial, and the reported data shows only the raw numbers without additional context about how the groups compared statistically. Any figures not included in the submitted results — such as breakdowns by hearing shift type — were not reported and cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01940705 · results posted 21 February 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 269 adults across four groups, all of whom were new hearing aid users. The four groups were: standard care alone (66 people), standard care plus a printed hearing aid information guide (67 people), standard care plus a take-home DVD (69 people), and standard care plus a counselling technique called "teach-back," where clinicians check understanding by asking patients to repeat information back in their own words (67 people). By the end of the study, 245 people had completed it. The trial was measuring how well participants understood and could manage their hearing aids — things like changing batteries and inserting the device correctly — as well as how confident they felt using their hearing aids and their overall satisfaction with them. The reported data shows that on the main test — a combined knowledge and skills assessment scored out of 100% — all four groups scored in a similar range. At the first measurement point, scores were: standard care 65.4%, information guide 68.3%, DVD 66.2%, and teach-back 74.6%. At the second measurement point, scores were: standard care 77.3%, information guide 80.3%, DVD 78.9%, and teach-back 83.0%. For the confidence questionnaire (scored 0–100, where 100 means complete confidence), the reported scores were 77.1, 78.4, 80.1, and 80.9 for the four groups respectively. For the satisfaction questionnaire (scored 7–35, where 35 is the highest possible), the reported scores were 29.3, 29.7, 29.7, and 30.0 across the four groups. The reported data shows relatively small numerical differences between the groups across all three measures. No further breakdown — such as whether those differences were considered statistically meaningful — was included in the data submitted to ClinicalTrials.gov, so that information is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02392403 · results posted 1 November 2018
According to the results reported on ClinicalTrials.gov, this trial involved 45 adults who received a Nucleus CI532 cochlear implant (a surgically inserted hearing device). Forty-two participants completed the study, and three did not finish. The trial was measuring a range of things, including where the implant's electrode array ended up inside the inner ear, how close it sat to a key inner-ear structure, how surgeons found the procedure, and how participants' speech understanding and self-reported hearing experience changed over six months. The reported data shows that, out of 44 participants who had their inner-ear positioning checked by a CT scan, all 44 had the electrode array located entirely within one chamber of the inner ear (called the scala tympani), and none were recorded in the other chamber. A measurement called the "wrapping factor" — a ratio that reflects how closely the array hugged the inner wall of the cochlea — was reported as 0.62. On surgeon experience, 38 out of the surgeons involved reported agreeing or strongly agreeing that the implant was easy to handle and insert. For speech understanding, the reported data shows average improvements of around 52–64 percentage points in the implanted ear alone and around 30–34 percentage points in best-aided listening conditions, though the individual figures behind these averages were not broken down further in the submitted data. A patient-reported wellbeing questionnaire (scored from −100 to +100, where 0 means no change) returned an average score of 28.1. A separate self-rated hearing questionnaire (scored 0–10, where higher is better) showed an average improvement of 2.22 points from the starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01934010 · results posted 9 March 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called AM-101, which was given as injections into the ear to treat tinnitus (ringing in the ears). A total of 257 people took part, split into three groups depending on how many treatment cycles they received: 114 people received 1 cycle, 67 received 2 cycles, and 76 received 3 cycles. The trial was primarily measuring whether the treatment was associated with any worsening of hearing — specifically, whether a person's ability to hear sounds dropped by 15 decibels or more across two neighbouring sound frequencies at various points in time after treatment. The reported data shows the number of participants in each group whose hearing appeared to worsen by that threshold at different check-up points. At the Day 35 check-up, 10 out of 114 people in the 1-cycle group, 2 out of 67 in the 2-cycle group, and 2 out of 76 in the 3-cycle group showed this level of hearing change. At Day 119, only the 2-cycle and 3-cycle groups were checked, with 1 person and 0 people respectively showing that degree of change. At Day 203, only the 3-cycle group was checked, and 2 people showed the hearing change. The secondary check-ups at Days 84, 168, and 252 showed similarly small numbers across the groups, with figures ranging from 0 to 10 people at any given time point. The reported data shows that these measurements were tracking changes in hearing over time across the different dosing groups. No figures were reported for some group-and-timepoint combinations, as those check-ups were not applicable to all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00683644 · results posted 13 December 2017
According to the results reported on ClinicalTrials.gov, this trial looked at whether zinc supplementation had any effect on tinnitus — the experience of ringing or other sounds in the ears. A total of 116 people took part, split into two groups of 58: one group received zinc first and the other received a placebo (a dummy treatment with no active ingredient) first. This was a "crossover" design, meaning participants eventually swapped treatments. By the end of the study, 45 people in the first group and 44 in the second group had completed the trial. The reported data shows that the primary measure was a questionnaire called the Tinnitus Handicap Questionnaire (THQ), scored from 0 (no tinnitus reaction) to 100 (worst possible reaction). The researchers noted that a change of 20 points or more on this scale was considered meaningful. For the zinc treatment, the reported average score was around 22–24 points, and for the placebo it was around 25 points. The reported data also shows scores from two secondary measures. On a loudness rating scale (0–100), average scores were approximately 68 for zinc and 66–68 for placebo. On an annoyance rating scale (0–100), average scores were approximately 60–61 for zinc and 58 for placebo. The data as submitted does not clearly separate baseline scores from end-of-treatment change scores for these secondary measures, so the precise before-and-after differences were not fully reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02345031 · results posted 19 September 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02345031) enrolled 78 people in total — 38 taking a capsule called AUT00063 (600 mg) and 40 taking a placebo (a dummy capsule with no active ingredient). Almost all participants finished the study: 37 in the AUT00063 group and 39 in the placebo group. The trial was measuring whether AUT00063 had any effect on hearing over four weeks, particularly how well people could understand speech when there was background noise, and how quickly the ear could process sounds in quick succession. The reported data shows that for the main measure — understanding speech in noisy conditions, tested using something called the QuickSIN test — both groups showed a small change from their starting point after four weeks. The AUT00063 group's score changed by –1.11 decibels on average, while the placebo group's score changed by –1.91 decibels on average (a negative number here means a small shift in the threshold needed to catch 50% of words in noise). For one of the secondary sound-processing tests (measuring how quickly the ear detects gaps in sound between different pitches), the AUT00063 group changed by –2.98 milliseconds and the placebo group by –10.72 milliseconds from their starting scores; on a similar test measuring gaps within the same pitch, the AUT00063 group changed by +4.45 milliseconds and the placebo group by +5.53 milliseconds. The reported data also shows that 23 out of 38 people in the AUT00063 group and 24 out of 40 people in the placebo group experienced at least one side effect during the study period. Blood levels of AUT00063 were also measured — the active treatment group had an average plasma level of 3,470.61 ng/ml at day 28, while the placebo group recorded zero, as would be expected. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02470494 · results posted 27 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 adults who used a hearing device called the EarLens Contact Hearing Device (CHD). The device sits on the eardrum and is designed to amplify sound. Of the 46 people who started, 41 completed the study and 5 did not finish. The trial was mainly measuring whether the device caused any change in participants' natural (unaided) hearing ability over roughly 90 days, and it also tracked several secondary measures including how well people could understand speech in noisy environments, how much amplification the device provided across a range of sound frequencies, and how participants felt about their own ability to communicate. The reported data shows the following results. For the primary measure — change in unaided hearing — the average difference was −0.5 decibels (dB), which the trial protocol described as "no hearing change" (defined as a shift of 10 dB or less). For the secondary measures: understanding speech in noise (using a test called HINT 90) showed an average change of +2.0 dB (where a negative number would have indicated improvement on this particular test); the device's amplification across higher sound frequencies (2,000–10,000 Hz) showed an average gain of 27.2 dB compared to unaided hearing; and participants' self-reported communication difficulty (measured by a questionnaire called APHAB) showed an average improvement score of 29 percentage points when wearing the device compared to without it. The adverse events data lists participant counts across several categories, though the specific labels for each category were not fully detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00785707 · results posted 26 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 children who received a cochlear implant (a surgically placed hearing device). Of those, 24 children completed the study, while 7 did not finish. The trial was measuring whether a parent-completed questionnaire called the LittleEARS Auditory Questionnaire (LEAQ) could be used to track how children's listening and hearing behaviours developed over time. The LEAQ is scored on a scale from 0 to 35, where a higher number reflects better auditory behaviour as reported by parents. The reported data shows that the primary goal of the study was to test whether the LEAQ questionnaire was a valid tool for measuring auditory behaviour in young children with cochlear implants. The average score recorded for this measure was 34.75 out of 35. For the secondary measure, the reported data shows the average change in LEAQ scores from when children first had their cochlear implant fitted to 24 months later was 28.78 points on the same 0–35 scale, meaning parents reported notably different responses to the questionnaire items over that period. No other outcome figures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01567020 · results posted 8 February 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 105 participants across four groups: 28 controls (healthy comparison participants), 46 veterans who had been exposed to blast (such as from explosions), 20 veterans with brain injuries not caused by blast, and 11 older adults. The trial was measuring how well participants could process sounds and auditory information, using a range of listening tests and self-reported questionnaires. Not everyone who started the trial completed it — 15 participants across all groups did not finish. The reported data shows results across several listening tests. On the Dichotic Digits Test (where higher scores out of 100 are better), the control group scored 99.1, blast-exposed veterans scored 95.2, non-blast brain injury veterans scored 96.6, and the older group scored 97.5. On the Gaps in Noise Test (where lower scores in milliseconds are better), the control group recorded 4.7, blast-exposed veterans 6.4, non-blast brain injury veterans 5.6, and the older group 4.7. On the Staggered Spondaic Words Test (where lower error counts out of 40 are better), the control group made 2.1 errors on average, blast-exposed veterans made 7.9, non-blast brain injury veterans made 5.0, and the older group made 4.1. A fifth test (Adaptive Tests of Temporal Resolution) was not reported due to a software problem during the study. For the secondary measures, the reported data shows that on a self-reported hearing difficulty questionnaire scored from 0 to 100 (higher meaning more perceived difficulty), the control group averaged 6.75 and blast-exposed veterans averaged 32.5. On a separate questionnaire about hearing in noisy environments scored from 9 to 36 (higher meaning more difficulty), controls averaged 15.2 and blast-exposed veterans averaged 19.9. On a brain-wave response measure looking at how the brain reacted to repeated sounds, controls showed a 65.74% change in response compared to 51.87% for blast-exposed veterans. Results for the non-blast brain injury and older groups were not reported for the secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01822119 · results posted 6 February 2017
According to the results reported on ClinicalTrials.gov, this trial involved 27 adults who received the Baha Attract System, a hearing device that is implanted using a magnet under the skin rather than a direct skin-penetrating attachment. All 27 participants completed the study. The trial was measuring changes in hearing levels — specifically, how much a person's ability to detect sounds changed after receiving the device, compared to having no hearing device at all before the operation. Measurements were taken at 12 weeks and again at 36 weeks (roughly three and nine months) after the procedure. The reported data shows that the main measure of hearing — called PTA4, which is simply an average of how softly a person can hear tones across four key pitches — improved by 18.4 decibels (dB) at both the 12-week and 36-week check-ins, when comparing the device-on situation to no device before surgery. A larger negative number here means sounds became detectable at quieter levels with the device. The reported data also shows results at individual sound pitches at 36 weeks, with changes ranging from around −25.2 dB at some frequencies to −4.2 dB at others, suggesting the degree of change varied across the pitch range. When the Baha Attract System was compared to a softband (a non-surgical way of trialling the same sound processor worn on a headband before the operation), the reported average difference was less than 1 dB, with small variations across individual pitches. For speech understanding in quiet, three separate scores were reported at 36 weeks: 50%, 46.4%, and 24.2% of words perceived — though the data does not explain why three separate figures were reported for this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01129141 · results posted 23 November 2016
According to the results reported on ClinicalTrials.gov, this trial involved 205 people in total — 101 in a group that received a telephone-delivered tinnitus management programme (called "Tele-PTM") and 104 in a waiting list control group (who did not receive the programme during the study period). The trial was measuring the impact of tinnitus on people's daily lives using a 25-question self-report tool called the Tinnitus Functional Index (TFI). On this scale, scores run from 0 to 100, where a higher number means tinnitus is causing more problems. By the end of the study, 86 people in the Tele-PTM group and 91 in the control group had completed the trial. The reported data shows that, at the start of the study, both groups had similar average TFI scores — 69.9 for the Tele-PTM group and 68.2 for the waiting list control group, suggesting both groups were experiencing a comparable level of tinnitus-related difficulty at baseline. At the later time point, the reported average TFI score for the Tele-PTM group had changed to 47.8, while the waiting list control group's average score was 66.8. The researchers who designed the TFI tool have previously suggested that a drop of 13 or more points on this scale may feel meaningful to an individual person — the reported numbers are presented here only to describe what was measured, not to draw any conclusions about the programme. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01092910 · results posted 23 February 2016
According to the results reported on ClinicalTrials.gov, this trial involved 57 people who received a device called the Esteem Implant, which is a fully implanted hearing device. The trial was measuring how well participants could hear speech after receiving the implant, compared to how well they heard with their hearing aids before the implant. Specifically, the trial tracked two hearing tests — one measuring the quietest level of sound at which someone can understand speech (called the speech reception threshold), and another measuring how accurately people could identify words. The trial also recorded serious device-related unwanted events and monitored inner ear function over time. The reported data shows that, on average, participants' speech reception threshold scores improved by around 10.6 decibels at one follow-up point and 11.4 decibels at another, compared to their pre-implant hearing aid scores — where a larger number represents a bigger change from before. For word recognition, the reported data shows an average improvement of approximately 21.7 percentage points at one timepoint and 19.8 percentage points at another, again compared to pre-implant scores with hearing aids. Six serious device-related unwanted events were recorded across the group. Inner ear function, measured by bone conduction testing, was reported as 55.6 dB HL at the pre-implant baseline, 55.6 dB HL at the four-month follow-up, and 55.3 dB HL at the ten-month follow-up, suggesting these figures remained broadly similar across those timepoints. Of the 57 people who started the trial, 52 completed it, with 5 not completing — though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02042404 · results posted 2 February 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a hearing device in two groups of adults with mild to severe hearing impairment. The main (primary) group had 43 participants, and a smaller preparatory (roll-in) group had 5 participants. Of the 43 in the main group, 38 completed the study and 5 did not finish. The trial was primarily measuring two things: whether people could correctly identify more spoken words when wearing the device compared to not wearing it, and whether wearing the device changed their underlying hearing ability (measured without the device) before and after the trial period. The reported data shows that, on average, participants in the main group correctly identified 37.6% more words when wearing the device compared to their unaided baseline — meaning without any device. For the hearing safety measure, the average change in unaided hearing levels before and after wearing the device was reported as approximately −0.4 decibels (dB), which falls well within the pre-set threshold of 10 dB or less that the researchers used to define "no hearing change." On a secondary measure looking at how well sounds were detected across a range of pitches (frequencies), the reported average difference between unaided and aided listening was about 30.5 dB. For a speech-in-noise test (understanding sentences when background noise is present), the reported average change was 0.75 dB — note that in this particular test, a negative number would indicate improvement, so this small positive value suggests little to no average change in that measure. The number of serious adverse events (unexpected harmful events) considered related to the device or procedure was reported as zero. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00724152 · results posted 17 April 2015
According to the results reported on ClinicalTrials.gov, this trial looked at three approaches for people experiencing tinnitus (ringing or noise in the ears): Cognitive Behavioural Therapy (CBT, a type of talking therapy focused on thought and behaviour patterns), a Tinnitus Education program, and Standard Care. The trial ran in two stages. In the first stage, 14 people were assigned to CBT and 11 to Tinnitus Education, with 11 and 9 of those respectively completing that stage. In the second stage, a further 4 people joined the CBT group, 2 joined the Tinnitus Education group, and 2 joined the Standard Care group, with 3, 0, and 1 completing that stage respectively. The reported data shows scores on two questionnaires used to measure how much tinnitus was affecting participants. The first was the Tinnitus Handicap Inventory (THI), scored from 0 to 100, where higher numbers mean greater impact from tinnitus. At the end of the first stage, the CBT group recorded an average score of 37.9 and the Tinnitus Education group recorded 45.1. In the second stage, the CBT group averaged 42.67 and the Tinnitus Education group averaged 26.0. A score for the Standard Care group in the second stage was not reported in the data. The second questionnaire, the Tinnitus Reaction Questionnaire (TRQ), is scored from 0 to 104 with higher scores indicating more distress. The reported data shows first-stage averages of 24.3 for CBT and 31.2 for Tinnitus Education, and second-stage averages of 29.3 for CBT and 15.0 for Tinnitus Education. Again, no Standard Care figure was reported for either questionnaire. It is worth noting that the number of participants in this trial was quite small, particularly in the second stage, which means these figures should be interpreted with considerable caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00371436 · results posted 8 April 2015
According to the results reported on ClinicalTrials.gov, this trial involved 181 people who experienced tinnitus (a persistent ringing or noise in the ears). Participants were split into two groups: 92 people received a structured program called "Tinnitus Progressive Management," and 89 received "Usual Care." The trial was measuring how much tinnitus affected participants' daily lives, using a questionnaire called the Tinnitus Handicap Inventory (THI). The THI gives a score from 0 to 100, where a higher number means a person feels more affected by their tinnitus. Not everyone completed the trial — 58 people in the Tinnitus Progressive Management group and 68 in the Usual Care group finished. The reported data shows THI scores for both groups. The Tinnitus Progressive Management group recorded scores of 37.0 and 33.0, while the Usual Care group recorded scores of 43.0 and 40.0. The data as submitted does not include labels clearly distinguishing which scores relate to which time points (for example, before or after the program), so it is not possible to describe the full context of these numbers with certainty. No other outcome measures were included in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01267994 · results posted 6 April 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants in a single open-label group — meaning everyone in the trial received the same treatment and both participants and researchers knew what was being given. Ten participants completed the trial, while two did not finish. The trial was looking at whether the drug anakinra might improve hearing test results in people with autoimmune inner ear disease whose condition had not responded to steroid treatment. Hearing was measured using audiometric thresholds — essentially a standard hearing test that records the softest sounds a person can hear. The reported data shows that, out of the participants assessed, 7 were recorded as "responders" on the primary measure — meaning their hearing test results showed improvement compared to their results before starting anakinra treatment. The trial tracked these results over a period of up to 180 days. For the secondary outcome, the reported data shows that zero serious adverse events (that is, significant medical problems considered serious enough to require reporting) were recorded among participants who received at least one injection of anakinra. It is important to note that this was a small trial with only 12 people, and the data does not include a comparison group that received no treatment, so the numbers should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01038336 · results posted 20 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 129 people in total, split across three groups: 43 people received a multimedia hearing loss prevention program, 42 received a hearing conservation brochure, and 44 received standard-of-care (that is, whatever would normally happen with no extra intervention). All 129 participants completed the study. The trial was measuring noise exposure and a range of attitudes and knowledge related to hearing protection, comparing the three approaches. The reported data shows that for the main (primary) outcome — the percentage of time participants spent in sound levels above 80 decibels, measured over seven days using a personal noise-measuring device — the multimedia program group recorded 4.4%, the brochure group recorded 5.0%, and the standard-of-care group recorded 6.3%. For the secondary outcomes, which looked at changes in hearing-related knowledge and attitudes between the start of the study and one month later, the reported numbers were generally small across all groups. Knowledge scores (measured as percentage of correct answers) increased by 11.5 points in the multimedia group, 15.0 points in the brochure group, and 4.7 points in the standard-of-care group. For attitudes — covering how much people felt at risk, how seriously they viewed hearing loss, how much they valued protecting their hearing, and how many barriers they felt to doing so — changes were recorded on a scale ranging from −50 to +50, and the reported shifts were modest across all three groups, ranging from small increases to small decreases depending on the group and the specific attitude being measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01539590 · results posted 4 November 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01539590) was set up to compare a treatment called BB3 against a placebo (an inactive dummy treatment) in people who had experienced a heart attack. The trial aimed to measure two main things: whether BB3 reduced the size of the damaged area of the heart (called infarct size, assessed using MRI scans), and whether it affected changes in the size and shape of the heart's main pumping chamber over six months. A total of five people were enrolled — three in the BB3 group and two in the placebo group. The reported data shows that the trial did not reach its intended conclusions. Of the three people in the BB3 group, none completed the full study, and only one completed the full course of treatment. Both participants in the placebo group completed the study. Because so few people took part and the trial did not fully complete, no numerical results were reported for any of the outcome measures — including the primary measures of heart damage size and heart chamber changes, or any of the secondary measures such as blood marker levels (CK-MB, Troponin, and BNP) and heart function assessments. The data for all outcomes is listed as not reported on ClinicalTrials.gov. In other words, this trial was too small and too incomplete to produce any findings about what BB3 does or does not do. No numbers were submitted for any of the measurements the trial originally set out to capture. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00716976 · results posted 26 February 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 131 people in total — 65 in the group that received a drug called sodium thiosulfate (STS) alongside their treatment, and 66 in an observation-only group who did not receive STS. The trial was measuring whether hearing loss occurred less often in the STS group compared to the observation group. Hearing loss was assessed by comparing each participant's hearing test results before and after the study using a standard set of criteria. Not everyone completed the trial — 45 of the 65 STS participants and 57 of the 66 observation participants finished. The reported data shows that, among those assessed for the primary outcome, 14 participants in the STS group were recorded as having hearing loss, compared to 31 participants in the observation group. For the secondary outcomes, the trial also tracked average changes in hearing sensitivity across five specific sound frequencies (measured in decibels, where a higher positive number means hearing became less sensitive — that is, it took a louder sound to hear). The reported data shows the following average changes: at 500 Hz, −1.45 dB (STS) versus −1.11 dB (observation); at 1,000 Hz, −0.68 dB versus −0.32 dB; at 2,000 Hz, −1.18 dB versus +0.64 dB; at 4,000 Hz, +1.05 dB versus +9.58 dB; and at 8,000 Hz, +9.73 dB versus +17.0 dB. A negative number here means hearing sensitivity slightly improved on average, while a positive number means it declined somewhat. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00477607 · results posted 29 January 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 39 people — 19 in the alpha-lipoic acid group and 20 in the placebo group. The trial was looking at whether alpha-lipoic acid (a dietary supplement) could reduce hearing damage caused by cisplatin, a chemotherapy drug known to affect hearing. By the end of the study, 12 people in the alpha-lipoic acid group and 13 in the placebo group had completed the trial, with 7 people in each group not finishing. The reported data shows that for the main outcome — measuring significant hearing loss in the frequency range most sensitive to cisplatin-related damage — 7 out of 12 participants in the alpha-lipoic acid group and 7 out of 13 in the placebo group experienced this type of hearing loss. The reported data also shows a secondary measure called malondialdehyde (MDA), which is a marker of a certain kind of cell stress in the body. The maximum increase in MDA levels from the start of the trial was reported as 0.27 micro-moles per litre in the alpha-lipoic acid group, compared with 0.47 micro-moles per litre in the placebo group. For a third measure — the total amount of cisplatin actually given during treatment — the alpha-lipoic acid group received a reported average of 239.7 mg/m² and the placebo group received 191.5 mg/m². It is worth noting that this was a relatively small trial, and the numbers above are simply what was recorded and submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01395368 · results posted 23 August 2012
According to the results reported on ClinicalTrials.gov, this trial involved 108 people who all had tinnitus (a ringing or noise in the ears). Of those who started, 92 people completed the study, while 16 did not finish. The trial was measuring performance on something called the Brain Speed Test, which is a cognitive (thinking and processing) test. Scores were adjusted for age so that results could be fairly compared across participants of different ages. The reported data shows one primary outcome measure: an age-adjusted score on the Brain Speed Test. The scoring system used is called a "z-score," which is simply a way of showing how far someone's result sits from the average score of a typical person their age. A z-score of 0 means exactly average, and scores above +2 or below −2 are considered noticeably different from the general population. The reported average z-score for the tinnitus group was −0.09, which the scoring system's own description would place very close to the average for their age group. No secondary outcome measure data was reported in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00787189 · results posted 11 July 2011
According to the results reported on ClinicalTrials.gov, this trial involved 64 people in total — 32 in an active treatment group and 32 in a control group. The trial was measuring changes in word recognition ability, specifically whether participants' hearing test scores improved by a meaningful amount after receiving the study treatment. To test this, participants listened to a list of single-syllable words through headphones and repeated back what they heard, with scores recorded separately for each ear. The trial ran until 30 people in each group completed it, with 2 people in each group not finishing. The reported data shows that the main outcome being tracked was whether each participant's word recognition score improved by at least a certain amount — as defined by a reference chart — when comparing their score before the study to their score one week after treatment. According to the results reported on ClinicalTrials.gov, 15 out of 30 participants in the active group met this threshold, compared to 2 out of 30 participants in the control group. No other outcome measures were included in the submitted results data, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.