Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) (Baha)
|ClinicalTrials.gov Identifier: NCT01264510|
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was: Active, not recruiting
First Posted : December 21, 2010
Last Update Posted : December 5, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Conductive Hearing Loss Mixed Hearing Loss Unilateral Deafness||Other: audiological test battery||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
|patients implanted with a Bone-anchored hearing aid(Baha)||
Other: audiological test battery
routine audiological measurements.
- 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.
- evaluation of subjective benefit of the Baha [ Time Frame: after 3 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264510
|University Hospital Ghent|
|Principal Investigator:||Ingeborg Dhooge, MD, PhD||University Hospital, Ghent|