Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)

NCT ID: NCT01264510

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2015-08-31

Brief Summary

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A bone-anchored hearing aid (Baha) consists of a titanium implant located at the mastoid, and a sound processor connected with the implant. The sound processor delivers bone conducted stimuli to the cochlea, bypassing the outer and middle ear.

Some patients who are unable to wear or do not benefit from a conventional air-conduction hearing aid, are candidate for a Baha. Typically, these patients suffer from a conductive or a mixed hearing loss. Recently however, Baha's are also being recommended in patients with unilateral deafness. Sound coming from the deaf side is captured and transmitted through bone conduction to the normal inner ear. The overall benefit of a Baha is more difficult to assess in those patients.

Therefore, the goal of the current study is to examine the benefit of a Baha in patients with different audiological profiles (unilateral or bilateral conductive or mixed hearing loss, and unilateral deafness). Special attention will be given to predictive determinants of the benefit with a Baha, and to the improvement of pre-operative criteria and counseling of patients.

Detailed Description

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Conditions

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Conductive Hearing Loss Mixed Hearing Loss Unilateral Deafness

Keywords

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conductive hearing loss mixed hearing loss unilateral deafness implanted with Baha conductive or mixed hearing loss implanted with a Baha or unilateral deafness implanted with a Baha

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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patients implanted with a Bone-anchored hearing aid(Baha)

Group Type OTHER

audiological test battery

Intervention Type OTHER

routine audiological measurements.

Interventions

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audiological test battery

routine audiological measurements.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients (males and females) already implanted with a bone-anchored hearing aid (Baha) are included in the study.
* Only patients above 18 years will be included.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingeborg Dhooge, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website University Hospital Ghent

Other Identifiers

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2010/074

Identifier Type: -

Identifier Source: org_study_id