Evaluation of a Hearing Device for Transmitting Sound to the Inner Ear

NCT ID: NCT05628285

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-11-15

Brief Summary

A single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.

Detailed Description

Bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. Bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. This evaluation focus on a sound processor used for a transcutaneous system.

Conditions

Conductive Hearing Loss; Mixed Hearing Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sentio 1 sound processor

The sound processor picks up the sound and transfer it to the implant that convert the sound to vibrations that are transmitted to the inner ear.

Group Type: EXPERIMENTAL

Sentio 1

Intervention Type: DEVICE

Sound processor

Interventions

Sentio 1

Sound processor

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Signed Informed Consent Form

2. Adult subjects (18 years or older)

3. Subjects implanted with an I1 implant

4. Fluent in Swedish

Exclusion Criteria

1. Subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion.

2. Subject deemed unsuitable for any medical or other reason as judged by PI or medical responsible.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oticon Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ann-Charlotte Persson

Role: PRINCIPAL_INVESTIGATOR

Habilitation & Health, Hearing organization Södra Gubberogatan 6, 416 63 Göteborg, Sweden

Locations

Habilitation & Health, Hearing organization

Gothenburg, , Sweden

Countries

Sweden

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BC114

Identifier Type: -

Identifier Source: org_study_id