Evaluation of Actual Maximum Gain in Bone Anchored Devices

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.

NCT Number	NCT07294976
Lead Sponsor	Oticon Medical Collaborators: Göteborg University
Conditions	Mixed Hearing Loss
Enrollment	20 participants
Start Date	2025-12-04
Primary Completion	2026-01-15 (estimated)
Study Completion	2026-01-15 (estimated)
Updated on ClinicalTrials.gov	2025-12-19