Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness

Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness

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

Study Overview

• Status: Completed
• Conditions: Unilateral Deafness
• Intervention / Treatment: Device: Bone-anchored hearing aid

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • New York Eye & Ear Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; normal hearing sensitivity
2; Unilateral deafness who are implanted with a Bone Anchored Hearing Aid	Device: Bone-anchored hearing aid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HINT score	Hearing in Noise Test	Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
CNC score	Consonant-nucleus-consonant speech-recognition test	Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA
Localization	Localization in sound field test	Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abbreviated Profiles of Hearing Aid Benefit	Questionnaire	3 months post BAHA, 6 months post BAHA, 1 year post BAHA

Collaborators and Investigators

• Sponsor: The New York Eye & Ear Infirmary
• Collaborators: The Jacob and Valeria Langeloth Foundation
• Investigators: Principal Investigator: Christopher J Linstrom, MD, New York Eye & Ear Infirmary; Principal Investigator: Carol A Silverman, PhD, MPH, New York Eye & Ear Infirmary

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 20, 2005

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Unilateral deafness; Unilateral hearing loss; Bone anchored hearing aid
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Unilateral
• Other Study ID Numbers: 03.33; 000303