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Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201617
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 14, 2015
The Jacob and Valeria Langeloth Foundation
Information provided by:
The New York Eye & Ear Infirmary

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

Condition or disease Intervention/treatment
Unilateral Deafness 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.

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Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
Study Start Date : July 2004
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. HINT score [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA ]
    Hearing in Noise Test

  2. CNC score [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA ]
    Consonant-nucleus-consonant speech-recognition test

  3. Localization [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA ]
    Localization in sound field test

Secondary Outcome Measures :
  1. Abbreviated Profiles of Hearing Aid Benefit [ Time Frame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201617

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United States, New York
New York Eye & Ear Infirmary
New York, New York, United States, 10003
Sponsors and Collaborators
The New York Eye & Ear Infirmary
The Jacob and Valeria Langeloth Foundation
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Principal Investigator: Christopher J Linstrom, MD New York Eye & Ear Infirmary
Principal Investigator: Carol A Silverman, PhD, MPH New York Eye & Ear Infirmary
Layout table for additonal information Identifier: NCT00201617    
Other Study ID Numbers: 03.33
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 14, 2015
Last Verified: April 2015
Keywords provided by The New York Eye & Ear Infirmary:
Unilateral hearing loss
Unilateral deafness
Bone anchored hearing aid
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases