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Evaluation of Actual Maximum Gain in Bone Anchored Devices

RecruitingNAAges 18 Years - anyAllOticon Medical
NCT07294976 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ampl

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. BAHS user with an Oticon Medical compatible abutment 2. Signed Informed Consent Form 3. Adult, 18 years or older 4. 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 5. 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 6. At least 3 months of experience using a bone conduction device. 7. Fluent in Swedish to be able to read and understand patient information and informed consent process Exclusion Criteria: 1. Participation in another clinical investigation which might cause interference with study participation. 2. Subjects who do not have the ability or are unwilling to follow investigational procedures/requirements, e.g. to complete questionnaires, according to investigator's discretion.
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What it tests

  • Bone Anchored Device A
  • Bone Anchored Device B
  • Bone Anchored Device C
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Where

1 site
Göteborgs Universitet
Gothenburg, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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