As a result of the FDA final rules on over-the-counter hearing aids (see FDA Regulations for Over-the-Counter Hearing Aid Sales) the Board has been requested to provide guidance to licensees. The final FDA rule creates two classes of hearing aids, over-the-counter (OTC) and prescription, where one previously existed. The sale of OTC hearing aids is not within the purview of the board, the ruling qualifies that OTC hearing aids are only intended for adults with perceived mild-to-moderate hearing loss. As such, it would be unsafe for licensees to recommend over-the-counter hearing aids for children. Licensees are to continue to follow all state statutes under Article 22. Licensure Act for Speech and Language Pathologists and Audiologists and rules under the North Carolina Administrative Chapter 64, surrounding assessment and dispensing of traditional or “prescription” hearing aids for adults and children.
Guidance for Industry and FDA Staff: This guide supersedes the February 25, 2009 version.
Federal Register: FDA Public Inspection
American Academy of Audiology OTC Hearing Aid Resource Page
Additional board guidance regarding: OTC hearing aids and traditional or “prescription” hearing aids