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.

Study Overview

• Status: Recruiting
• Conditions: Mixed Hearing Loss
• Intervention / Treatment: Device: Bone Anchored Device A; Device: Bone Anchored Device B; Device: Bone Anchored Device C

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marianne Philipsson Senior Clinical Trial Manager; Phone Number: +46 (0)70 098 17 15; Email: maph@oticonmedical.com

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Goteborgs Universitet
    • Contact: Sadeghi; Phone Number: +46737531418; Email: andre.sadeghi@neuro.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All study participants; All study patients will sequentially be measured with Device A, Device B and Device C	Device: Bone Anchored Device A; Fitting Device A; Device: Bone Anchored Device B; Fitting Device B; Device: Bone Anchored Device C; Fitting Device C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Number of subjects with a limitation of the prescribed gain in any frequency band with Device A, Device B and Device C	Baseline, at fitting

Collaborators and Investigators

• Sponsor: Oticon Medical
• Collaborators: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): January 15, 2026

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: December 15, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Loss; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: BC126

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No