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

NCT01264510 | Withdrawn Phase 4

• 1 other identifier: 2010/074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Conductive Hearing Loss; Mixed Hearing Loss; Unilateral Deafness

Keywords

conductive hearing loss; mixed hearing loss; unilateral deafness; implanted with Baha; conductive or mixed hearing loss implanted with a Baha or; unilateral deafness implanted with a Baha

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• evaluation of subjective benefit of the Baha

  after 3 months

Study Arms (1)

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

OTHER

Other: audiological test battery

Interventions

audiological test battery OTHER

routine audiological measurements.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

University Hospital Ghent

Ghent, Belgium

Location

Related Links

• website University Hospital Ghent

MeSH Terms

Conditions

Hearing Loss, Conductive; Hearing Loss, Mixed Conductive-Sensorineural; Hearing Loss, Unilateral

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ingeborg Dhooge, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: December 21, 2010
• Study Start: March 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

BE (1)