Evaluation of Actual Maximum Gain in Bone Anchored Devices

Oticon Medical

Status: Enrolling

Conditions: Mixed Hearing Loss

Treatments: Device: Bone Anchored Device A; Device: Bone Anchored Device B; Device: Bone Anchored Device C

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07294976

BC126

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

All study participants

Experimental group

Description:

All study patients will sequentially be measured with Device A, Device B and Device C

Treatment:

Device: Bone Anchored Device C

Device: Bone Anchored Device B

Device: Bone Anchored Device A