NCT07294976

Evaluation of Actual Maximum Gain in Bone Anchored Devices

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mixed Hearing Loss

Interventions

Type	Name	Description
DEVICE	Bone Anchored Device A	Fitting Device A
DEVICE	Bone Anchored Device B	Fitting Device B
DEVICE	Bone Anchored Device C	Fitting Device C

Timeline

• Start date: 2025-12-04
• Primary completion: 2026-01-15
• Completion: 2026-01-15
• First posted: 2025-12-19
• Last updated: 2025-12-19

Locations

1 site across 1 country: Sweden