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Real-World Benefit From Directional Hearing Aids

This study has been completed.

Sponsors and Collaborators: Vanderbilt University
Department of Veterans Affairs
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00438334
  Purpose

Directional microphone hearing aids have been shown to provide benefit for individuals with hearing loss in a number of laboratory experiments. However, few studies have investigated the real-world, subject-reported benefit from these hearing aids, and even fewer have examined directional hearing aid benefit across varying degrees of hearing loss. This study will summarize data from a three-year, multi-faceted study of directional hearing aid benefit. Ninety four subjects were divided into three hearing loss groups (normal-to-moderate, mild-to-moderately-severe, and moderate-to-profound). These subjects were then fit with experimental hearing aids set to either directional or omnidirectional mode to determine if significant differences were present in hearing aid outcomes (both subjective and objective). Both subject and experimenter were blinded to the hearing aid settings. Following one month of use in each experimental setting, subjects completed: probe microphone measurements, speech understanding in noise testing, use questionnaires, subjective benefit scales, and satisfaction scales. At the conclusion of the study, subjects rated their preferences for the experimental settings in quiet, noise and overall. Both objective measures, as well as subjective data, were analyzed across hearing aid and hearing loss conditions.


Condition Intervention
Hearing Loss
Device: Programmable directional/omni-directional hearing aid

Genetics Home Reference related topics:   nonsyndromic deafness   

MedlinePlus related topics:   Hearing Disorders and Deafness    Noise   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment
Official Title:   Real-World Benefit From Directional Microphone Hearing Aids

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Probe microphone measurements
  • Speech understanding in noise
  • Hearing aid use time
  • Hearing aid benefit
  • Hearing aid preference
  • Hearing aid satisfaction

Estimated Enrollment:   105
Study Start Date:   April 2001
Estimated Study Completion Date:   March 2004

Show detailed description  Show Detailed Description

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • 105 subjects were recruited for participation in this study, thirty-five in each of three hearing loss groups.
  • Subjects were assigned to the three groups according to the severity of their hearing losses.
  • Group 1 (mild) subjects exhibited normal sloping to moderately severe SNHL, with Pure Tone Averages (PTAs) at 500, 1000, and 2000 Hz of less than 35 dB HL.
  • Group 2 (moderate) consisted of subjects with mild sloping to moderately severe SNHL with PTAs of 35 to 50 dB HL.
  • Group 3 (severe) subjects exhibited moderately-severe, sloping to severe-profound SNHL, with PTAs of greater than 50.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438334

Locations
United States, Tennessee
Department of Veterans Affairs Medical Center    
      Nashville, Tennessee, United States, 37232

Sponsors and Collaborators
Vanderbilt University
Department of Veterans Affairs

Investigators
Principal Investigator:     David Gnewikow, Ph.D.     Vanderbilt University    
  More Information


Study ID Numbers:   000170
First Received:   December 5, 2006
Last Updated:   February 21, 2007
ClinicalTrials.gov Identifier:   NCT00438334
Health Authority:   United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Benefit  
Directional microphones  
Hearing  
Hearing aids  
Hearing loss  
Noise
Objective benefit
Signal-to-noise ratio
Speech understanding
Subjective benefit

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Neurologic Manifestations
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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