Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07294976

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Göteborgs Universitet

Gothenburg, Sweden

Actively Recruiting

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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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Evaluation of Actual Maximum Gain in Bone Anchored Devices | DecenTrialz