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HEARING AID "QUALITY OF LIFE" PROMOTIONAL CLAIMS

This article was originally published in The Gray Sheet

Executive Summary

HEARING AID "QUALITY OF LIFE" PROMOTIONAL CLAIMS should not require clinical studies, the Heating Industries Association argues in a March 22 citizen petition to FDA. The association characterizes FDA's assertion that clinical studies are necessary to support "general, nonmedical quality of life claims associated with hearing aid use" as "extreme" and argues that "if the underlying claim that a hearing aid is effective is substantiated, no reason exists" for separate substantiation of quality of life claims.
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