Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) (Baha)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
University Hospital, Ghent

April 22, 2010
December 21, 2010
December 5, 2014
March 2010
August 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01264510 on Archive Site
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.
Same as current
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Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha)
The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness

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.

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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Conductive Hearing Loss
  • Mixed Hearing Loss
  • Unilateral Deafness
Other: audiological test battery
routine audiological measurements.
patients implanted with a Bone-anchored hearing aid(Baha)
Intervention: Other: audiological test battery
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
August 2015
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Ingeborg Dhooge, MD, PhD University Hospital, Ghent
University Hospital, Ghent
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP