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

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Brief Title

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

Official Title

The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness

Brief Summary

      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.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles

Secondary Outcome

 evaluation of subjective benefit of the Baha

Condition

Conductive Hearing Loss

Intervention

audiological test battery

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

150

Start Date

March 2010

Completion Date

August 2015

Primary Completion Date

August 2015

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ingeborg Dhooge, MD, PhD, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT01264510

Organization ID

2010/074


Responsible Party

Sponsor

Study Sponsor

University Hospital, Ghent


Study Sponsor

Ingeborg Dhooge, MD, PhD, Principal Investigator, University Hospital, Ghent


Verification Date

December 2014