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Hearing aid user instructional brochures

This article was originally published in The Gray Sheet

Executive Summary

FDA "has grossly underestimated the burden placed on hearing aid manufacturers by" requiring them to provide instructional brochures to users, the Hearing Industries Association maintains in Aug. 31 comments to the agency. Whereas FDA in its proposed estimate of the annual reporting provision assumes that firms provide only one brochure for each different hearing aid model, the companies "surveyed by HIA produced six more brochures than models of hearing aids," HIA says. In addition, FDA assumes that 40 staff hours are sufficient to produce each brochure, "but the average number of staff hours per brochure" for HIA-member companies participating in an "informal survey" was "over 136 hours," the group contends
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