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Real-World Benefit From Directional Hearing Aids

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438334
First Posted: February 22, 2007
Last Update Posted: November 22, 2016
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.
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
Vanderbilt University
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Real-World Benefit From Directional Microphone Hearing Aids

Resource links provided by NLM:


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

Enrollment: 105
Study Start Date: April 2001
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00438334


Locations
United States, Tennessee
Department of Veterans Affairs Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
VA Office of Research and Development
Investigators
Principal Investigator: David Gnewikow, Ph.D. Vanderbilt University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00438334     History of Changes
Other Study ID Numbers: 000170
First Submitted: December 5, 2006
First Posted: February 22, 2007
Last Update Posted: November 22, 2016
Last Verified: November 2016

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

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