A review of the FDA Notice of Proposed Rulemaking (NPRM) on OTC Hearing Aids reveals a wide disparity in the fundamental data in the record. To assist our readers in developing their comments on the NPRM we are providing for easy reference three critical documents.
Notwithstanding the fact that two of above documents were prepared by governmental bodies and specifically address the subject matter in the OTC Notice of Proposed Rulemaking, it is puzzling why the FDA would summarily dismiss these documents by not even mentioning them for public comment in the NPRM and instead devote their complete attention to a standard recommended by a trade association.
