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

Conductive Hearing Loss Clinical Trial

— Baha  

Official title:

The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01264510
• Other study ID #: 2010/074
• Status: Withdrawn
• Phase: Phase 4
• Start date: March 2010
• Est. completion date: August 2015

Study information

• Verified date: December 2022
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Hearing Loss, Mixed Conductive-Sensorineural
• Hearing Loss, Unilateral
• Mixed Hearing Loss
• Unilateral Deafness

Intervention

Other:
• audiological test battery
routine audiological measurements.

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles	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.	after 3 months up to 10 years
Secondary	evaluation of subjective benefit of the Baha	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.	after 3 months

External Links

•   website University Hospital Ghent