Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
This trial is active, not recruiting.
|Conditions||conductive hearing loss, mixed hearing loss, unilateral deafness|
|Treatment||audiological test battery|
|Sponsor||University Hospital, Ghent|
|Start date||March 2010|
|End date||August 2015|
|Trial size||150 participants|
|Trial identifier||NCT01264510, 2010/074|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
time frame: after 3 months up to 10 years
evaluation of subjective benefit of the Baha
time frame: after 3 months
Male or female participants at least 18 years old.
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.
|Official title||The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness|
|Principal investigator||Ingeborg Dhooge, MD, PhD|
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