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Evaluation of Actual Maximum Gain in Bone Anchored Devices

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• BAHS user with an Oticon Medical compatible abutment

• Signed Informed Consent Form

• Adult, 18 years or older

• 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

• 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

• At least 3 months of experience using a bone conduction device.

• Fluent in Swedish to be able to read and understand patient information and informed consent process

Locations
Other Locations
Sweden
Göteborgs Universitet
RECRUITING
Gothenburg
Contact Information
Primary
Marianne Philipsson Senior Clinical Trial Manager
maph@oticonmedical.com
+46 (0)70 098 17 15
Time Frame
Start Date: 2025-12-04
Estimated Completion Date: 2026-01-15
Participants
Target number of participants: 20
Treatments
Experimental: All study participants
All study patients will sequentially be measured with Device A, Device B and Device C
Related Therapeutic Areas
Sponsors
Leads: Oticon Medical
Collaborators: Göteborg University

This content was sourced from clinicaltrials.gov