Clinical Trial: Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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.
Detailed Summary:
Sponsor: University Hospital, Ghent
Current Primary Outcome: benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles [ Time Frame: after 3 months up to 10 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: evaluation of subjective benefit of the Baha [ Time Frame: after 3 months ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Ghent
Dates:
Date Received: April 22, 2010
Date Started: March 2010
Date Completion: August 2015
Last Updated: December 4, 2014
Last Verified: December 2014