Three Key Studies Needed to Address the FDA NPRM on OTC Hearing Aids

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.