Comparing the maximum sound boost from different bone-anchored hearing devices.
Official title: Evaluation of Actual Maximum Gain in Bone Anchored Devices
Run by Oticon Medical · NCT07294976 · Data updated 2026-11-12
This project will test how much extra sound three bone-anchored hearing devices can deliver for adults with mixed hearing loss.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Oticon Medical Industry-sponsored |
| Locations | 1 site (Gothenburg) |
| Status | Recruiting |
| Started | December 4, 2025 |
| Main results expected | January 15, 2026 |
| Study ends | January 15, 2026 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07294976 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with mixed hearing loss who already use a bone conduction device, have an Oticon Medical compatible abutment, a bone-conduction PTA of 25–65 dB HL, an air-bone gap of at least 15 dB, at least three months' device experience, and fluency in Swedish.
✕Probably not a fit
People without an Oticon Medical compatible abutment, children, those outside the specified hearing thresholds, or those unable or unwilling to complete study procedures or questionnaires are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults who already use a bone-anchored hearing system will try each of three devices (Devices A, B, and C) while researchers measure the actual maximum amplification, or gain, each device provides with real-world feedback control during fitting. The trial will directly compare Device A vs B, A vs C, and B vs C to see whether devices differ in the amplification they can deliver and whether those limits affect the prescribed settings. Standard audiometric measures and fitting procedures will be used to record bone- and air-conduction thresholds and device output. Testing will be conducted at the University of Gothenburg with participants who meet the study's device and language requirements.
Why it matters
Potential benefit: If successful, the results could help clinicians pick and program bone-anchored devices to give patients stronger, more appropriate amplification.
How similar studies have gone: Bone-anchored hearing systems are well established for mixed hearing loss, but direct head-to-head comparisons of actual maximum amplification under fitted feedback control are limited, so this specific comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. BAHS user with an Oticon Medical compatible abutment 2. Signed Informed Consent Form 3. Adult, 18 years or older 4. MHL with pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of 25-65dB HL on the indicated ear 5. MHL with an air-bone-gap (difference between BC and AC thresholds) of at least 15 dB measured at 0.5, 1, 2 and 3 kHz 6. At least 3 months of experience using a bone conduction device. 7. Fluent in Swedish to be able to read and understand patient information and informed consent process Exclusion Criteria: 1. Participation in another clinical investigation which might cause interference with study participation. 2. Subjects who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
Where it's running
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Göteborgs Universitet
Gothenburg, Sweden Recruiting
Study contacts
- Study coordinator: Marianne Philipsson Senior Clinical Trial Manager
- Email: maph@oticonmedical.com
- Phone: +46 (0)70 098 17 15
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.