Following President Joe Biden’s July 9, 2022 Executive Order on Promoting Competition in the American Economy, which was intended to “promote the wide availability of low-cost hearing aids,” on August 16, 2022, the US Food and Drug Administration (“FDA”) issued a final rule for Over-the-Counter (“OTC”) access to hearing aids. FDA’s new final rule establishes a new category for OTC hearing aids for consumers with “perceived mild to moderate hearing impairment who wish to buy lower cost hearing aids not bundled with professional services and not requiring professional advice, fitting, adjustment, or maintenance.” Therefore, consumers will now be able to purchase hearing aids directly from retailers, without the need for a prescription from their physician. FDA expects that the new rule will lower the cost of hearing aids and improve access for millions of Americans.
The FDA Reauthorization Act of 2017 (“FDARA”) amended the Federal Food, Drug, and Cosmetic Act (the “Act”) to “revise and extend the user-fee programs for drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.” Among its provisions, FDARA amended 21 U.S.C. 360j by defining “over-the-counter” hearing aids as, among other things, being intended for use by people over the age of 18 and older in order to compensate for mild to moderate hearing impairment and through various means allows the user to control the hearing aid to suit their individual needs. Furthermore, FDARA provided FDA with the authority to promulgate regulations “to establish a category of over-the-counter hearing aids…” The August 16, 2022 final rule on OTC hearing aids does just that by “establishing a regulatory category for OTC hearing aids to improve access to hearing aid technology for Americans.”
The new rule, codified at 21 C.F.R. § 800.3, defines hearing aids as “any wearable device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing” and provides a series of (1) labeling requirements, (2) output limits, (3) electroacoustic performance limits, (4) design requirements, (5) conditions for the sale of an OTC hearing aid, and (6) effects on state law. Those hearing aids that do not meet the regulatory requirements for OTC hearing aids, for instance, if their intended use population is under 18, would still be considered prescription devices under the new framework.
Israel is a hotbed of hearing aid technologies and FDA’s new regulations stand to be a game changer for innovators seeking access to the US medical device market. For instance, on July 12, 2022, the Jerusalem Post reported that Israeli startup “Tuned” just completed a $5 million financing round for its AI-enabled hearing technology. Last year, Israel HaYom reported on Israel’s “Alango Technologies” who seek to bring “hyper advanced” functionality to hearing aids. Israeli companies that manufacture hearing aids can now seek to make them available to consumers as OTC products.
 87 FR 50699.
 See, Public Law 115–52.
 Id. Also see 21 U.S.C. 360j(q)).
 87 FR 50698.
 21 C.F.R. § 800.3(b).