Evaluation of Sound Processor for a Transcutaneous System

NCT ID: NCT03374787

Last Updated: 2025-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-15

Study Completion Date

2018-11-22

Brief Summary

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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 speech intelligibility and self evaluation questionnaires.

Detailed Description

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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

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Conductive Hearing Loss Mixed Hearing Loss

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Fusion 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

Fusion Sound Processor

Intervention Type DEVICE

Sound Processor

Interventions

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Fusion Sound Processor

Sound Processor

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects implanted with the Bridging Bone Conductor (BBC) implant
* Subjects that have completed one year follow up in Osseofon BCI (Bone Conduction Implant) study
* Subjects available for 6 months study procedures without affecting the follow ups in the Osseofon BCI study
* Active user of the BCI SP

Exclusion Criteria

* Inability to participate in follow-ups
* Unsuitable as judged by the principle investigator or the sub-investigator
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

Oticon Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Måns Eeg Olofsson, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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ENT departement, Sahlgrenska University Hospital

Gothenburg, , Sweden

Site Status

Countries

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Sweden

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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C58

Identifier Type: -

Identifier Source: org_study_id

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