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| 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 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment |
| Official Title: | Real-World Benefit From Directional Microphone Hearing Aids |
| Estimated Enrollment: | 105 |
| Study Start Date: | April 2001 |
| Estimated Study Completion Date: | March 2004 |
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Show Detailed Description |
Eligibility
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations| United States, Tennessee | |||||
| Department of Veterans Affairs Medical Center | |||||
| Nashville, Tennessee, United States, 37232 | |||||
| Vanderbilt University |
| Department of Veterans Affairs |
| 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 |
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