Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness

NCT ID: NCT00201617

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 28 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2007-08-31

Brief Summary

The purpose of this 3-year prospective investigation is to examine the short-term and long-term (1 year)efficacy of the bone-anchored hearing aid (BAHA) in adults with single sided deafness

Detailed Description

Limited studies have been done on the BAHA in adults with single sided (sensorineural) deafness, and these studies have evaluated only short-term efficacy at one month post implantation. The findings of the limited number of studies to date on the BAHA with single sided deafness demonstrate that the BAHA improves understanding in noisy or group situations and understanding conversation when addressed by a speaker on the side of the bad ear and most users have judged the BAHA to have at least satisfactory benefit. But conflicting findings have been obtained regarding whether the BAHA improves the ability to locate the source of a sound. Additionally, no studies have been done to see whether the magnitudes of the improvements seen at one month post implantation increase over time because of learning effects or brain plasticity.

This investigation will show whether the previously reported BAHA benefits at one month post BAHA sound processor fitting, related to speech recognition in noise and subjective satisfaction, persist at one year, and whether learning effects increase the magnitudes of these benefits from one month to one year post BAHA sound processor fitting. This long-term investigation also attempts to resolve the conflicting findings pertaining to the BAHA effect on localization abilities.

Subjects with hearing impairment will comprise 20 adults with single sided deafness who consent to remediation with the BAHA.In order to see how the adults with unilateral hearing loss will differ from the normal-hearing subjects over time, a control group of 20 normal-hearing individuals also will be evaluated over time, to see how closely the results of the unilateral deafness group approximate the results of the normal individuals.

Conditions

Unilateral Deafness

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

1

normal hearing sensitivity

No interventions assigned to this group

2

Unilateral deafness who are implanted with a Bone Anchored Hearing Aid

Bone-anchored hearing aid

Intervention Type: DEVICE

Interventions

Bone-anchored hearing aid

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Adult-onset deafness

2. Deafness is unilateral - complete or near complete

Exclusion Criteria

1. the presence of a developmental disorder or mental retardation;

2. history of drug abuse;

3. psychiatric disease;

4. inability to follow instructions or to participate in follow-up appointments

5. inability to use the BAHA

6. lack of osseo-integration -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Jacob and Valeria Langeloth Foundation

OTHER

Sponsor Role: collaborator

The New York Eye & Ear Infirmary

OTHER

Sponsor Role: lead

Principal Investigators

Christopher J Linstrom, MD

Role: PRINCIPAL_INVESTIGATOR

New York Eye & Ear Infirmary

Carol A Silverman, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

New York Eye & Ear Infirmary

Locations

New York Eye & Ear Infirmary

New York, New York, United States

Countries

United States

Other Identifiers

000303

Identifier Type: -

Identifier Source: secondary_id

03.33

Identifier Type: -

Identifier Source: org_study_id