Comparative Study of Non-surgical Hearing Devices Based on Bone Conduction

May 6, 2026 updated by: Oticon Medical
This study will investigate the performance of four non-surgical bone conduction devices.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Signed Informed Consent Form
  2. Adults (from 18 to 84 years)
  3. Pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) less than 25 dB HL on both ears
  4. 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. Participants 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1

Device:

Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D
Other: Bone conduction devices
Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in aided thresholds between device A and device B for PTA4.
Time Frame: Baseline, at fitting
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
Baseline, at fitting

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in aided thresholds between device A and device C for PTA4.
Time Frame: Baseline, at fitting
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
Baseline, at fitting
Difference in aided thresholds between device A and device D for PTA4.
Time Frame: Baseline, at fitting
PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.
Baseline, at fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oticon Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC124

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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