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

Sponsor

University Hospital, Ghent (Other)

Overall Status

Unknown status

CT.gov ID

NCT01264510

Collaborator

(none)

150

Enrollment

Location

Arm

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Conductive Hearing Loss Mixed Hearing Loss Unilateral Deafness	Other: audiological test battery	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2010

Anticipated Primary Completion Date :

Aug 1, 2015

Anticipated Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: patients implanted with a Bone-anchored hearing aid(Baha)	Other: audiological test battery routine audiological measurements.

Arm

Intervention/Treatment

Other: patients implanted with a Bone-anchored hearing aid(Baha)

Other: audiological test battery

routine audiological measurements.

Outcome Measures

Primary Outcome Measures

benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles [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 Outcome Measures

evaluation of subjective benefit of the Baha [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.