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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01264510
First received: April 22, 2010
Last updated: February 1, 2013
Last verified: February 2013

April 22, 2010
February 1, 2013
March 2010
August 2013   (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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01264510 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
August 2013
August 2013   (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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01264510
2010/074
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Ingeborg Dhooge, MD, PhD University Hospital, Ghent
University Hospital, Ghent
February 2013

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