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Retailers Looking To Sell Hearing Aids Over the Counter Must Meet the Applicable FDA Medical Device Rules

October 27, 2022

On Oct. 17, the U.S. Food and Drug Administration’s (FDA) final rule on over-the-counter (OTC) hearing aids took effect which now allows any person, 18 years of age or older, to buy or lease a hearing aid for mild to moderate hearing loss without a medical exam, prescription, or fitting. Neither the Medicare program nor many private insurance carriers cover the cost of hearing aids which can run anywhere from $2,500 to more than $5,000. The FDA’s new OTC hearing aid rule provides retailers a great opportunity to offer hearing aids over the counter at more affordable prices to millions of consumers. Complying with FDA’s hearing aid regulations will allow retailers to take full advantage of this unique opportunity without running afoul of the law.

The Basics

The OTC hearing aids can be sold direct to the consumer at any retail store, either in person, by mail, or online through the internet. The new rule includes certain Class I and Class II hearing aids. These OTC hearing aids cannot be implanted or surgically installed. The FDA OTC hearing aid rule allows retailers to offer OTC hearing aids without an exam, prescription, or fitting. Retailers do not need a licensed professional (e.g. audiologist) to dispense the OTC hearing aids. The OTC hearing aids can be sold on the shelf next to other medical products that do not require an exam or prescription (e.g. reading glasses). The FDA rule preempts certain state and local rules that would prevent the sale of FDA-approved OTC hearing aids.

The Requirements

The new FDA OTC hearing aid rule incorporates existing FDA medical device regulations along with new specific requirements that are necessary in order to be FDA compliant and sell OTC hearing aids to the general public. For example, OTC hearing aids must include do-it-yourself volume controls, meet certain performance and output limits, incorporate specific design requirements, be sold in appropriate packaging, have the proper interior and exterior package and product labeling, and provide the appropriate instructions, guidance, and warnings. These OTC hearing aids are generally exempt from premarket notification requirements. However, the FDA’s new OTC hearing aid rule does not waive certain existing FDA medical device rules regarding adulteration, misbranding, registration, banned devices, certain notifications, record keeping, reports, and remedies. Any hearing aid that does not meet the FDA’s new OTC hearing aid or applicable FDA medical device regulations cannot be sold as an OTC hearing aid. Violations of these FDA hearing aid or medical device regulations may subject retailers to FDA enforcement actions including an injunction, detention and/or destruction of hearing aids, monetary penalties, or criminal prosecution.

Are You Prepared?

Retailers are rushing to sell OTC hearing aids, but are they prepared to meet the FDA’s strict requirements? To succeed in OTC hearing aid sales, retailers need to carefully analyze FDA’s hearing aid regulations and implement the correct standards. In a rush, retailers can easily miss or fail to meet FDA’s requirements and be faced with an FDA enforcement action including an injunction, product seizure, or fines.

Clark Hill’s Healthcare team is ready to assist retailers in meeting FDA’s new OTC hearing aid and applicable medical device regulations in order to successfully sell OTC hearing aids directly to consumers in person, by mail, or online.

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For further information, please contact the author, Jose Vela Jr.

The views and opinions expressed in the article represent the view of the author and not necessarily the official view of Clark Hill PLC. Nothing in this article constitutes professional legal advice nor is it intended to be a substitute for professional legal advice.

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