On Oct. 19, 2021, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would establish a new category of over-the-counter (OTC) hearing aids. The rule came in response to President Joe Biden’s July 9 executive order, which among other things, calls for wide availability of low-cost hearing aids in order to promote economic competition.

If finalized, the proposed rule will provide improved access to hearing aids for adults 18 and over who have mild to moderate hearing loss. The FDA expects the rule to foster innovation in hearing aid technology by allowing manufacturers to benefit from a new market line that, historically, has been financially restrictive in terms of reimbursement.

Hearing aids are currently restricted class I and class II medical devices. The proposed rule would define a new class of OTC hearing aids that would be subject to output limits and labeling, electroacoustic performance, and design and fit requirements. Comparatively, class I and class II hearing aids will no longer be considered “restricted devices” under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the sale, distribution, or use of such devices without an order from an authorized health care provider. However, hearing aid products which do not meet the proposed rule’s definition of “OTC hearing aid” will be considered “prescription hearing aids” and will be subject to certain prescription requirements. The FDA does not expect the prescription requirements to increase the burden associated with obtaining a prescription hearing aid.

In order to ease regulatory burden for manufacturers offering both categories of devices, the proposed rule also creates consistent labeling practices among OTC and prescription hearing aids. During this proposal phase, the FDA is soliciting input on corresponding quality system regulations that would seek to ensure safety and effectiveness of OTC hearing aids while minimizing regulatory burden.

If this proposed rule is effectuated, OTC hearing aids will become available without the supervision, prescription, or involvement of a “licensed person,” such as an audiologist or physician. However, availability will implicate state and local laws. To ease confusion with existing state regulations, the FDA clarified it does not interpret the proposed rule to interfere with or preempt any state’s ability to establish professional licensure requirements.

The FDA offered several examples to reduce confusion about when the proposed rule will preempt state or local requirements involving hearing products. For example, nothing in the proposed rule exempts pharmacies or other entities from complying with state licensing requirements merely because they sell OTC hearing aids. However, the proposed rule would prohibit states from creating or enforcing licensure requirements based on the sale of OTC hearing aids. In other words, states may not mandate that an entity obtain any certification or licensure before selling OTC hearing aids. In the event that a state requires any level of involvement of licensed persons as a condition for consumers to gain access to OTC hearing aids, these limitations would be preempted by the FDA’s proposed rule.

In sum, the proposed rule attempts to remove barriers to marketplace entry for new hearing aid manufacturers while simultaneously providing millions of Americans affected by hearing loss with access to hearing aids. Manufacturers, distributors, and retailers of hearing aid products will need to evaluate the legal issues underpinning the FDA’s proposed rule. If your organization is involved in or evaluating the potential manufacture, distribution, or sale of hearing aid products, or would otherwise like to submit comments on the proposed rule by the Jan. 18, 2022, deadline, please contact a Dinsmore Life Sciences or Health Care Attorney for more information.