Efficacy of the Bone-Anchored Hearing Aid for Unilateral Deafness

This study has been completed.
Sponsor:
Collaborator:
The Jacob and Valeria Langeloth Foundation
Information provided by:
The New York Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00201617
First received: September 12, 2005
Last updated: November 16, 2007
Last verified: November 2007

September 12, 2005
November 16, 2007
July 2004
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Complete list of historical versions of study NCT00201617 on ClinicalTrials.gov Archive Site
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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

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Unilateral Deafness
Device: Bone-anchored hearing aid
  • 1
    normal hearing sensitivity
  • 2
    Unilateral deafness who are implanted with a Bone Anchored Hearing Aid
    Intervention: Device: Bone-anchored hearing aid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2007
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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 -
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201617
03.33, 000303
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The New York Eye & Ear Infirmary
The Jacob and Valeria Langeloth Foundation
Principal Investigator: Christopher J Linstrom, MD New York Eye & Ear Infirmary
Principal Investigator: Carol A Silverman, PhD, MPH New York Eye & Ear Infirmary
The New York Eye & Ear Infirmary
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP