NCT07294976

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

December 4, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2026

Completed
Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

November 27, 2025

Last Update Submit

December 15, 2025

Conditions

Mixed Hearing Loss

Outcome Measures

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

    Baseline, at fitting

Secondary Outcomes (6)

  • 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

    Baseline, at fitting

  • 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

    Baseline, at fitting

  • 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

    Baseline, at fitting

  • 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

    Baseline, at fitting

  • 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

    Baseline, at fitting

  • +1 more secondary outcomes

Study Arms (1)

All study participants

EXPERIMENTAL

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

Device: Bone Anchored Device ADevice: Bone Anchored Device BDevice: Bone Anchored Device C

Interventions

Bone Anchored Device ADEVICE

Fitting Device A

All study participants
Bone Anchored Device BDEVICE

Fitting Device B

All study participants
Bone Anchored Device CDEVICE

Fitting Device C

All study participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Göteborgs Universitet

Gothenburg, Sweden

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Marianne Philipsson Senior Clinical Trial Manager

CONTACT

+46 (0)70 098 17 15maph@oticonmedical.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

December 19, 2025

Study Start

December 4, 2025

Primary Completion

January 15, 2026

Study Completion

January 15, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)