AUDIOLOGY ADVOCATE | Over-the-Counter Hearing Aids and Implications for State Statutes and Regulations

By Susan Pilch 

This article is a part of the January/February 2023, Volume 35, Number 1, Audiology Today issue.

This document is intended for informational purposes and does not, and is not intended to, constitute legal advice. Please consult qualified professional counsel for any state-specific matter.

Overview

The Over-the-Counter Hearing Aid Act of 2017 directed the United States Food and Drug Administration (FDA) to create a new category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss available for use by consumers without professional assistance. The final rule implementing this law became effective October 17, 2022, and provides that “no state or local government shall establish or continue in effect any law, regulation, order, or other requirement specifically related to hearing products that would restrict or interfere with the servicing, marketing, sale, dispensing, use, customer support, or distribution of OTC hearing aids” [21 CFR 800.30(h)(1)]. This final rule has implications for existing state laws that were enacted to regulate certain aspects of traditional hearing aids.

Definition of Hearing Aid

Under the final FDA regulation, all hearing aids now fall into two categories: “over-the-counter” and “prescription.” Currently, state statutes and regulations do not distinguish between these two categories and may simply include a general definition of a hearing aid. States will need to create separate definitions for “OTC” and “prescription” hearing aids to take into account those types of regulatory actions that may be allowed for prescription hearing aids but may not be allowed for OTC devices per the FDA regulation. The FDA has provided clarification that the designation of traditional hearing aids as “prescription” is not intended to make any changes to the current state licensure requirements necessary to order or provide these devices. 

The FDA defines “OTC hearing aids” as devices “available over the counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online” [21 CFR 800.30(b)]. 

The FDA defines “prescription hearing aids” as all those that are not OTC hearing aids, and by way of example—all those subject to the requirements in §801.109, including that they “be sold only to or on the prescription or other order of [a] practitioner…licensed by law to use or order the use of the device or prescribe.”