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

NCT07580287 | Not Yet Recruiting

• 1 other identifier: BC124
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate the performance of four non-surgical bone conduction devices.

Conditions

Mixed Hearing Loss; Conductive Hearing Loss

Keywords

Bone conduction hearing devices; conductive hearing loss; mixed hearing loss; bone conduction

Outcome Measures

Primary Outcomes (1)

• Difference in aided thresholds between device A and device B for PTA4.

  PTA4 is the calculated average hearing thresholds at frequencies 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz.

  Baseline, at fitting

Secondary Outcomes (2)

• Difference in aided thresholds between device A and device C for PTA4.

  Baseline, at fitting

• Difference in aided thresholds between device A and device D for PTA4.

  Baseline, at fitting

Study Arms (1)

Arm 1

OTHER

Device: Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D

Other: Bone conduction devices

Interventions

Bone conduction devices OTHER

Bone Anchored device A Bone Anchored device B Bone Anchored device C Bone Anchored device D

Arm 1

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent Form
• Adults (from 18 to 84 years)
• 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
• 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.
• 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.

Sponsors & Collaborators

• Oticon Medical: lead

Study Sites (1)

Chalmers

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Louise Waldenby

CONTACT

+46735165389; lowd@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: May 6, 2026
• First Posted: May 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)