Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07294976

Evaluation of Actual Maximum Gain in Bone Anchored Devices

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Mixed Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Mixed Conductive-Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Participation in another clinical investigation which might cause interference with study participation.
  • 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.

Treatment and study plan

Bone Anchored Device A

Device

Fitting Device A

Bone Anchored Device B

Device

Fitting Device B

Bone Anchored Device C

Device

Fitting Device C

Primary outcomes

  1. Difference in actual maximum gain in dB, between Device A compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000

    Time frame: Baseline, at fitting

Secondary outcomes

  1. Difference in actual maximum gain in dB, between Device A compared to Device B for the for the mean average of the frequencies 500, 1000, 2000 and 4000

    Time frame: Baseline, at fitting

  2. Difference in actual maximum gain in dB, between Device A compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz

    Time frame: Baseline, at fitting

  3. Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000, 3000 and 4000

    Time frame: Baseline, at fitting

  4. Difference in actual maximum gain in dB, between Device C compared to Device B for the mean average of the frequencies 500, 1000, 2000 and 4000

    Time frame: Baseline, at fitting

  5. Difference in actual maximum gain in dB, between Device C compared to Device B across frequencies 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 and 8000 kHz

    Time frame: Baseline, at fitting

  6. Number of subjects with a limitation of the prescribed gain in any frequency band with Device A, Device B and Device C

    Time frame: Baseline, at fitting

Study contacts

Contact information is provided by the study sponsor or research team.

Marianne Philipsson Senior Clinical Trial Manager

CONTACT

[email protected]

+46 (0)70 098 17 15

Sponsors and collaborators

Lead sponsor

Oticon Medical

Industry

Collaborators

  • Göteborg University

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.