Real-World Benefit From Directional Hearing Aids
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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-Blind Primary Purpose: Treatment |
| Official Title: | Real-World Benefit From Directional Microphone Hearing Aids |
- 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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, Tennessee | |
| Department of Veterans Affairs Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | David Gnewikow, Ph.D. | Vanderbilt University |
More Information
No publications provided by Vanderbilt University
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00438334 History of Changes |
| Other Study ID Numbers: | 000170 |
| Study First Received: | December 5, 2006 |
| Last Updated: | February 21, 2007 |
| 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 |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013