Academy of Doctors of Audiology
October 13, 2022
FDA Provides Important Clarification to States Regarding Final FDA Rule on OTC Hearing Aids
Posted in: All News

Today, the U.S. Food and Drug Administration (FDA) distributed a letter to state officials providing important clarifications about the Final Rule on OTC Hearing Aids.

In part, the letter states, “We have received questions about some implications of these actions, including who may prescribe hearing aids and whether medical evaluations are necessary to obtain non-OTC hearing aids, which will be defined as prescription hearing aids under the rule. We clarify below that the final rule:

  • Does not change the necessary qualifications of who may provide hearing healthcare with prescription hearing aids, including the recommendation, selection, fitting, and dispensing of these devices;
  • Does not require an additional professional to take actions, for example, does not in any way require a physician’s involvement prior to fitting these devices; and
  • Does not require an examination of any kind to obtain a prescription hearing aid.”

This FDA letter was issued in response to requests by ADA and other organizations that the FDA provide clarification regarding implications for the Final Rule and the re-categorization of non-OTC hearing aids as prescription devices. ADA applauds the FDA for taking this swift action to provide clarifications to states, in advance of the October 17, 2022, Final Rule implementation date.

While this action does not negate the need for audiologists to advocate for timely updates to state regulations and statutes in response to the new regulations, it does provide states with an understanding of the FDA’s position, including …

“the final rule defining non-OTC hearing aids as prescription devices does not, and is not intended to, create barriers to accessing hearing aids, including prescription devices. It does not require the involvement of different or additional health care providers or examinations upon the effective date.”

It is unclear what immediate impact the clarification letter may have on state actions related to OTC and prescription hearing aids. ADA will continue to gather information and update members as new/additional information becomes available.