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American Journal of Audiology Vol.7 85-100 October 1998. doi:10.1044/1059-0889(1998/017)
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A Clinical Trial of the ReSound BT2 Personal Hearing System

Brian E. Walden 1, Rauna K. Surr 1, Mary T. Cord 1, and Chaslav V. Pavlovic 2

1 Walter Reed Army Medical Center, Washington, DC
2 ReSound Corporation, Redwood City, CA

Walden{at}WRAIR-EMH1.ARMY.MIL

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.

Key Words: clinical trials protocol, hearing aid benefit, ReSound BT2 Personal Hearing System

Submitted on July 14, 1997
Accepted on May 12, 1998






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