NCT07294976 Evaluation of Actual Maximum Gain in Bone Anchored Devices
| NCT ID | NCT07294976 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oticon Medical |
| Condition | Mixed Hearing Loss |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2026-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-12-04 with a primary completion date of 2026-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will look at how much sound amplification (gain) different bone-anchored hearing devices can provide. The goal is to understand if there are differences between devices and whether these differences affect how well the devices meet the hearing needs of users. Bone-anchored hearing systems send sound vibrations directly to the inner ear through a small implant in the skull. The amount of amplification a device can provide is important for people with hearing loss. However, the actual maximum amplification available to a user depends on feedback control during fitting and can vary between devices and individuals. In this study, the actual maximum amplification of Device A and Device B will be compared. In addition the actual maximum amplification of Device A will be compared to Device C as well as the Device B compared to Device C. It will also be investigated whether the amplification limits the prescribed settings for the users.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07294976 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mixed Hearing Loss. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07294976 currently recruiting?
Yes, NCT07294976 is actively recruiting participants. Contact the research team at maph@oticonmedical.com for enrollment information.
Where is the NCT07294976 trial being conducted?
This trial is being conducted at Gothenburg, Sweden.
Who is sponsoring the NCT07294976 clinical trial?
NCT07294976 is sponsored by Oticon Medical. The trial plans to enroll 20 participants.