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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
  Purpose

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 Intervention
Unilateral Deafness
Device: Bone-anchored hearing aid

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Short-Term and Long-Term Efficacy of the BAHA for Single Sided Deafness

Resource links provided by NLM:


Further study details as provided by The New York Eye & Ear Infirmary:

Enrollment: 28
Study Start Date: July 2004
Study Completion Date: August 2007
Groups/Cohorts Assigned Interventions
1
normal hearing sensitivity
2
Unilateral deafness who are implanted with a Bone Anchored Hearing Aid
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201617

Locations
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
Investigators
Principal Investigator: Christopher J Linstrom, MD New York Eye & Ear Infirmary
Principal Investigator: Carol A Silverman, PhD, MPH New York Eye & Ear Infirmary
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00201617     History of Changes
Other Study ID Numbers: 03.33, 000303
Study First Received: September 12, 2005
Last Updated: November 16, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by The New York Eye & Ear Infirmary:
Unilateral hearing loss
Unilateral deafness
Bone anchored hearing aid

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Loss, Unilateral
Ear Diseases
Hearing Disorders
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms

ClinicalTrials.gov processed this record on November 23, 2014