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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.
 
ClinicalTrials.gov Identifier: NCT00201617
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 14, 2015
Sponsor:
Collaborator:
The Jacob and Valeria Langeloth Foundation
Information provided by:
The New York Eye & Ear Infirmary

Tracking Information
First Submitted Date September 12, 2005
First Posted Date September 20, 2005
Last Update Posted Date April 14, 2015
Study Start Date July 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: April 13, 2015)
  • HINT score [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA, and 1 year post BAHA ]
    Hearing in Noise Test
  • 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
  • Localization [ Time Frame: Pre-BAHA, 3 mos post BAHA, 6 mos post BAHA ]
    Localization in sound field test
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: April 13, 2015)
Abbreviated Profiles of Hearing Aid Benefit [ Time Frame: 3 months post BAHA, 6 months post BAHA, 1 year post BAHA ]
Questionnaire
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of the Bone-anchored Hearing Aid for Unilateral Deafness
Official Title Short-term and Long-term Efficacy of the BAHA for Single Sided Deafness
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Unilateral Deafness
Intervention Device: Bone-anchored hearing aid
Study Groups/Cohorts
  • 1
    normal hearing sensitivity
  • 2
    Unilateral deafness who are implanted with a Bone Anchored Hearing Aid
    Intervention: Device: Bone-anchored hearing aid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 16, 2007)
28
Original Enrollment
 (submitted: September 12, 2005)
40
Actual Study Completion Date August 2007
Primary Completion Date Not Provided
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 -
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00201617
Other Study ID Numbers 03.33
000303
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study 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
PRS Account The New York Eye & Ear Infirmary
Verification Date April 2015