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HEARING AID CLAIMS FOR IMPROVED SPEECH INTELLIGIBILITY IN NOISE

This article was originally published in The Gray Sheet

Executive Summary

HEARING AID CLAIMS FOR IMPROVED SPEECH INTELLIGIBILITY IN NOISE must be substantiated through "double-blind (subject and tester), randomized, controlled" studies "at a minimum of two independent, audiometric laboratory facilities," FDA says in a recent draft clinical protocol focusing on hearing aid claims of efficacy in noisy environments. Such claims are a "priority concern," the agency states, since "one of the most difficult listening environments is when a hearing impaired person has to contend with background noise."
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