Trial 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
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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 37552281) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Hearing Loss Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You have hearing loss in the ear to be treated that is either conductive (sound not reaching the inner ear properly) or mixed (a combination of types), with inner ear function within a certain range measured by a hearing test — OR you are deaf in one ear while the other ear has near-normal hearing, OR you were recommended a certain type of hearing device (AC CROS) but cannot or will not use one.
- You are 18 years of age or older.
- You have previously used some form of hearing device, such as a hearing aid or a bone conduction device worn on a headband.
- You are a fluent speaker of the language used in the hearing tests for this trial.
- You are willing and able to sign a written consent form agreeing to take part.
Who may not be able to join:
- You have diabetes that is not well controlled, as assessed by the trial doctor.
- You have a medical condition that could affect how well the implant bonds with your bone or how well your wound heals (for example, osteoporosis, psoriasis, or long-term use of steroid medications).
- Your bone in the area of implantation is not strong or thick enough to safely hold the implant.
- You have previously had surgery or a bone-anchored implant on the same side being treated that could affect the new implant, as judged by the trial doctor.
- You are taking medications known to be harmful to hearing, as judged by the trial doctor.
- You are unable or unwilling to follow the study procedures, such as completing quality-of-life questionnaires.
- You have a medical condition that is likely to get worse over time or cause relapses that could seriously affect your general health and wellbeing, as judged by the trial doctor.
- You have had radiation therapy in the area where the implant would be placed, or you are expected to have such treatment during the study.
- You work at the trial site and are directly involved in running this study, or you are an immediate family member (spouse, parent, child, or sibling) of someone who is.
- You are an employee of Cochlear (the company behind this study) or of any organisation contracted by Cochlear to run this trial.
- You are currently taking part in, or have taken part in within the last 30 days, another clinical trial involving an experimental drug or medical device.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Karin Ganlöv, Cochlear
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
2 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Condition Assessed Via Audiometric Thresholds; Change in Hearing Performance With the Osia 2 System at 3 Months Post-surgery Compared to Preoperative Unaided Situation Assessed Via Adaptive Speech Recognition in Noise
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.