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.
Dr. Johnson’s work was authored as part of the Contributor’s official duties as an Employee of the United States Government and is therefore a work of the United States Government. Dr. Earl E. Johnson is a Coordinator of Research at the Department of Veterans Affairs and is the author of Safety limit warning levels for the avoidance of excessive sound amplification to protect against further hearing loss.
Dr. Anil K. Lalwani is the Vice Chair for Research, Director of Division of Otology, Neurotology & Skull Base Surgery, Co-Director of Columbia Cochlear Implant Program in the Department of Otolaryngology and the Medical Director of Perioperative Services at New York-Presbyterian Hospital/CUIMC
Safe listening guidelines for personal sound amplifiers
