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 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.
View full results on ClinicalTrials.gov ↗
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 are 18 years old or older
- You have a type of hearing loss called conductive or mixed hearing loss in the ear to be treated, with bone hearing test results reaching a certain level of loss (confirm with trial site)
- OR you have complete hearing loss in one ear (single-sided deafness) and have been considered suitable for a type of bone-anchored hearing implant surgery
- OR you have been recommended a specific type of hearing device that routes sound from your deaf side to your good ear, but are unable or unwilling to use it
- You have previously used some form of hearing device, such as a hearing aid, headband bone conduction device, or similar non-surgical solution
- You are willing and able to sign a consent form agreeing to take part
Who may not be able to join:
- You have diabetes that is not well controlled, as determined by the study doctor
- You have a health condition that could affect how well your body heals or accepts an implant (for example, osteoporosis, psoriasis, or long-term use of steroid medications)
- You do not have enough suitable bone in the area where the implant would be placed
- You have had radiation therapy to the area where the implant would go, or are expected to have it during the study
- You are taking certain medications that could be harmful to your hearing, as determined by the study doctor
- You are unable to follow the study procedures, such as completing questionnaires about your quality of life
- You are currently taking part in another clinical trial involving a medical device or medication
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: Emmanuel Mylanus, Prof., Radboud Univerity Medical centre
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
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Hearing Performance: Threshold Audiometry, Pure Tone Average of 4 Frequencies, PTA4, Unaided Versus OSIA System at 3 Months; Adaptive Speech Recognition in Noise, Unaided Versus OSIA System at 3 Months.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.