FDA Clarification Letter on the Impact of OTC Hearing Aid Rule on States

October 17, 2022

As over-the-counter (OTC) hearing aids officially hit the market today for people with self-perceived mild to moderate hearing loss, the Food and Drug Administration (FDA) has issued an important letter to state officials [PDF] clarifying the effect of its final OTC rule on non-OTC hearing aids. In response to requests from ASHA [PDF] and other advocacy groups, the agency addressed two critical components of the FDA rule: 1) the designation of non-OTC hearing aids as “prescription devices” and 2) the repeal of federal medical evaluation requirements.

Designation of Non-OTC Hearing Aids as Prescription Devices

The FDA letter clarifies 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.” Furthermore, the agency clarified that the OTC rule intends that “the same professionals who recommended, selected, fitted, and dispensed restricted hearing aids before the effective date would continue to do so for prescription hearing aids after the effective date.”

Repeal of Federal Medical Evaluation Requirements

The FDA letter further clarifies that the final rule “does not in any way require a physician’s involvement prior to fitting [prescription hearing aids]” and “[d]oes not require an examination of any kind to obtain a prescription hearing aid.” This clarification addresses concerns among some that the rule would require consumers to undergo a medical evaluation from a physician before obtaining a prescription hearing aid from an audiologist.

What’s Next?

ASHA is pleased that the FDA has confirmed that the OTC rule does not place new restrictions on fitting and dispensing traditional hearing aids. In the coming months, ASHA will continue to update members on collaborative advocacy efforts addressing OTC hearing aids.

If you have feedback or questions about ASHA’s work in this arena or how it impacts your state, please contact Tim Boyd, Director of State Health Care and Education Affairs, at states@asha.org

For comprehensive resources on educating patients about OTC hearing aids, promoting the continued value of an audiologist, and collaborating with other trusted professionals influencing OTC hearing aid decisions, please visit ASHA’s Over-the-Counter Hearing Aid Toolkit.

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