FDA Eliminates ‘Physician Waiver’ System in Hearing Aid Dispensing

The FDA issued a press release and guidance document explaining that it does not intend to enforce the requirement that individuals 18 and older receive a medical evaluation or sign a waiver prior to purchasing most hearing aids. The action addresses one of the key controversial points brought up in the recent NAS and PCAST sets of recommendations for improving accessibility to hearing aids. The FDA also announced its commitment to consider creating an OTC hearing aid category.