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Evaluation of Actual Maximum Gain in Bone Anchored Devices

NCT ID: NCT07294976

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-04

Study Completion Date

2026-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Mixed Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All study participants

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

Group Type EXPERIMENTAL

Bone Anchored Device A

Intervention Type DEVICE

Fitting Device A

Bone Anchored Device B

Intervention Type DEVICE

Fitting Device B

Bone Anchored Device C

Intervention Type DEVICE

Fitting Device C

Interventions

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Bone Anchored Device A

Fitting Device A

Intervention Type DEVICE

Bone Anchored Device B

Fitting Device B

Intervention Type DEVICE

Bone Anchored Device C

Fitting Device C

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role collaborator

Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Göteborgs Universitet

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Marianne Philipsson Senior Clinical Trial Manager

Role: CONTACT

Phone: +46 (0)70 098 17 15

Email: [email protected]

Facility Contacts

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Sadeghi

Role: primary

Other Identifiers

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BC126

Identifier Type: -

Identifier Source: org_study_id