The proposed rule would establish a regulatory category for over-the-counter (OTC) hearing aids and make related amendments to update the regulatory framework for hearing aids. The primary social benefits would be the availability of less costly hearing aids in states that currently disallow or restrict sales of hearing aids in venues and under conditions other than specialty retail stores by licensed professional bundled with professional services, such as online hearing aids, and a potential increase in the uptake of hearing aids particularly in such states but possibly more generally. The proposed rule would not impose significant additional costs on firms. Costs would include reading the rule, relabeling products, and revising SOPs as necessary. 

Regulatory Impact Analysis

OTC Hearing Aids PRIA (PDF- 324KB)

Docket: FDA-2021-N-0555

Federal Register: 86 FR 58150, October 20, 2021