Overview

This trial is active, not recruiting.

Conditions conductive hearing loss, mixed hearing loss, unilateral deafness
Treatment audiological test battery
Phase phase 4
Sponsor University Hospital, Ghent
Start date March 2010
End date August 2015
Trial size 150 participants
Trial identifier NCT01264510, 2010/074

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
audiological test battery
routine audiological measurements.

Primary Outcomes

Measure
benefit of a Bone-anchored hearing aid (Baha) in patients with different audiological profiles
time frame: after 3 months up to 10 years

Secondary Outcomes

Measure
evaluation of subjective benefit of the Baha
time frame: after 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Evaluation of the Effectiveness of Bone-anchored Hearing Aids (Baha) in Patients With Conductive or Mixed Hearing Loss, or Unilateral Deafness
Principal investigator Ingeborg Dhooge, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by University Hospital, Ghent.