The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Conductive Hearing Loss
- Sponsor
- University Hospital, Ghent
- Locations
- 1
- Primary Endpoint
- benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
Time Frame: after 3 months up to 10 years
Patients who are already implanted with a Baha at the University Hospital of Ghent will be re-evaluated once using an audiological test battery. This evaluation will take place at least 3 months after implantation for the recently implanted subjects. For the subjects who are implanted in the past, this evaluation will take place maximum 10 years after implantation. The audiological test battery includes measurements of hearing thresholds, speech understanding in quiet and noise, and auditory orientation tests.
Secondary Outcomes
- evaluation of subjective benefit of the Baha(after 3 months)