A Clinical Trial of the ReSound BT2 Personal Hearing System The Food and Drug Administration requires that hearing aid manufacturers substantiate benefit claims in advertising with clinical research. Recently, Walden (1997) described a model protocol that might be used to assess hearing aid benefit in manufacturer-sponsored clinical trials. The Walter Reed protocol includes laboratory measures of speech recognition ability using ... Research Article
Research Article  |   October 01, 1998
A Clinical Trial of the ReSound BT2 Personal Hearing System
 
Author Affiliations & Notes
  • Brian E. Walden, PhD
    Army Audiology & Speech Center, Walter Reed Army Medical Center, Washington, D.C. 20307-5001
  • Rauna K. Surr
    Army Audiology & Speech Center, Walter Reed Army Medical Center, Washington, D.C. 20307-5001
  • Mary T. Cord
    Army Audiology & Speech Center, Walter Reed Army Medical Center, Washington, D.C. 20307-5001
  • Chaslav V. Pavlovic
    ReSound Corporation, Redwood City, CA
Article Information
Hearing & Speech Perception / Hearing Disorders / Hearing Aids, Cochlear Implants & Assistive Technology / Research Articles
Research Article   |   October 01, 1998
A Clinical Trial of the ReSound BT2 Personal Hearing System
American Journal of Audiology, October 1998, Vol. 7, 85-100. doi:10.1044/1059-0889(1998/017)
History: Received July 14, 1997 , Accepted May 12, 1998
 
American Journal of Audiology, October 1998, Vol. 7, 85-100. doi:10.1044/1059-0889(1998/017)
History: Received July 14, 1997; Accepted May 12, 1998

The Food and Drug Administration requires that hearing aid manufacturers substantiate benefit claims in advertising with clinical research. Recently, Walden (1997) described a model protocol that might be used to assess hearing aid benefit in manufacturer-sponsored clinical trials. The Walter Reed protocol includes laboratory measures of speech recognition ability using the Continuous Speech Test (CST, Cox, Alexander, & Gilmore, 1987; Cox, Alexander, Gilmore, & Pusakulick, 1988) and the scales and subscales of the Profile of Hearing Aid Benefit (PHAB, Cox & Gilmore, 1990) to assess user benefit in four prototype listening environments.

A clinical trial of the ReSound BT2 Personal Hearing System (BT2 PHS) using the Walter Reed protocol is reported here. The results for 40 adult participants with moderate-to-severe acquired sensorineural hearing losses revealed significant benefit from the BT2 PHS as compared to unaided performance on most of the CST and PHAB measures.

Compared to performance (unaided) of persons with normal hearing, the individuals with hearing impairments obtained substantially poorer performance on the CST and reported slightly poorer BT2-aided performance on the PHAB. Finally, on average, participants reported significantly more success on the PHAB with the BT2 PHS as compared to their own linear hearing aids, and 70% of the participants preferred the BT2 PHS enough to be willing to purchase it rather than to continue to use their own government-issued linear hearing aids.

Acknowledgments
This work was sponsored by ReSound Corporation of Redwood City, CA, through a Cooperative Research and Development Agreement with the Clinical Investigation Regulatory Office, U.S. Army Medical Department in Ft. Sam Houston, TX. Additional support was received from the Department of Clinical Investigation, Walter Reed Army Medical Center in Washington, D.C. under Work Unit #2542.
The authors thank Jack Giroux, Craig Dunckel, Victor Bray, Jean Sullivan, Robyn Cox, Ken Grant, Van Summers, John Clay, and Franz Seitz for their contributions.
Portions of this work were presented at the 23rd International Congress of Audiology in Bari, Italy. The opinions and assertions presented are the private views of the authors and are not to be construed as official or as necessarily reflecting the views of the Department of the Army, the Department of Defense, or ReSound Corporation.
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