Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) (Baha)
Recruitment status was: Active, not recruiting
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.
Conductive Hearing Loss
Mixed Hearing Loss
Other: audiological test battery
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness|
- benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles [ Time Frame: after 3 months up to 10 years ] [ Designated as safety issue: No ]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.
- evaluation of subjective benefit of the Baha [ Time Frame: after 3 months ] [ Designated as safety issue: No ]The subjective benefit of the Baha in different situations will be evaluated by means of questionnaires. No measures regarding safety, tolerability or pain will be evaluated because these measures are already verified for the Baha. The outcome measures are strictly related to audiological factors (e.g. the difference in hearing thresholds/ speech understanding/ orientation with and without Baha). The test duration is estimated at 2 hours.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
|patients implanted with a Bone-anchored hearing aid(Baha)||
Other: audiological test battery
routine audiological measurements.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264510
|University Hospital Ghent|
|Principal Investigator:||Ingeborg Dhooge, MD, PhD||University Hospital, Ghent|