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 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.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 25634465) ↗
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 implanted that is caused by a problem with sound conduction (such as in the ear canal or middle ear), with inner ear hearing ability still relatively intact (confirmed by a specific hearing test result)
- You have total or near-total hearing loss in one ear due to nerve/inner ear damage, while the other ear has relatively good inner ear hearing (confirmed by a specific hearing test result)
- You are willing and able to sign a consent form agreeing to take part in the trial
Who may not be able to join:
- You have diabetes that is not well controlled, as decided by the doctor running the trial
- You have a condition that could affect how well a bone implant heals or bonds, such as osteoporosis or psoriasis, or you regularly use steroid medications
- You are unable to follow the study procedures, such as filling out questionnaires about your quality of life
- The soft tissue (skin and tissue) at the implant site measures less than 4mm thick before the operation
- You are currently taking part in another clinical study involving a drug or medical device
- You have any other condition that the trial doctor believes could affect the results of the study (confirm with trial site)
- You have previously had radiation therapy on the same side of the head where the device would be placed
- During surgery, the doctor finds that the bone in the intended implant location is not thick or strong enough to place the implant securely
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: Robert Cowan, A/Professor, The HEARing CRC & HearWorks, University of Melbourne
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, PTA4 at 12 Weeks; Hearing Performance, PTA4 at 36 Weeks
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.