Actively Recruiting
Evaluation of Actual Maximum Gain in Bone Anchored Devices
Led by Oticon Medical · Updated on 2025-12-19
20
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
Sponsors
O
Oticon Medical
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of Actual Maximum Gain in Bone Anchored Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BAHS user with an Oticon Medical compatible abutment
- Signed Informed Consent Form
- Adult, 18 years or older
- Mixed hearing loss with pure tone average bone conduction threshold of 25-65 dB HL in the indicated ear
- Mixed hearing loss with an air-bone gap of at least 15 dB at 0.5, 1, 2, and 3 kHz
- At least 3 months of experience using a bone conduction device
- Fluent in Swedish to understand patient information and consent process
You will not qualify if you...
- Participation in another clinical investigation that might interfere with this study
- Unable or unwilling to follow study procedures or complete questionnaires as required by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Göteborgs Universitet
Gothenburg, Sweden
Actively Recruiting
Research Team
M
Marianne Philipsson Senior Clinical Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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