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FDA In Brief

This article was originally published in The Gray Sheet

Executive Summary

August ENT panel meeting: FDA's Ear Nose and Throat Devices Panel will meet Aug. 16 in Gaithersburg, Maryland to discuss and make recommendations on the recently issued implantable middle ear hearing device draft guidance (1"The Gray Sheet" June 17, 2002, p. 11). Topics to be addressed include "appropriate study population, objective measurement techniques for comparison of acoustic hearing aids and middle ear hearing devices and subjective questionnaire development for determining postoperative effectiveness and quality of life outcomes," according to the 2ENT meeting announcement. Requests for formal oral presentations should be submitted to FDA by Aug. 8...
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