Many people suffer from hearing loss and related hearing problems. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing care professional in order to be properly diagnosed and fitted with a hearing aid. Now, as noted below, the United States Food and Drug Administration (FDA or Agency) has issued a final rule that changes the requirements so that no prescription is needed for people with hearing loss perceived as mild to moderate. The result will be that these people will be able to have easier access to hearing aids.
On August 16, 2022, the FDA finalized a long-awaited to reign creation of a new category of over-the-counter (OTC) hearing aids. This final rule only applies to people 18 and older with perceived mild to moderate hearing loss. The final rule will come into effect on October 17, 2022.
The FDA estimates that approximately 30 million people in the United States are affected by hearing loss, but only about one-fifth of this population seek intervention. According to the FDA, the final rule is intended to encourage competition and facilitate the sale of over-the-counter hearing aids in an effort to improve access to these devices for people with perceived mild to moderate hearing loss.
Under the final rule, consumers with perceived mild to moderate hearing loss will be able to buy hearing aids directly online or in retail stores without a medical exam, prescription or fitting by a licensed audiologist. Hearing aids that do not meet over-the-counter regulatory requirements (for example, intended for the severely hearing impaired or those under 18) will be considered prescription devices by the Agency.
The final rule will require OTC hearing aids to comply with regulatory requirements under 21 CFR § 800.30, which include labeling, performance, design requirements and other applicable requirements such as special controls. OTC hearing aids will also be subject to quality system requirements under 21 CFR Part 820. .
In response to comments submitted to the proposed rule published last October, the FDA made several notable changes to the final rule. These changes include reducing the maximum sound output, revising the ear canal insertion depth limit, requiring all over-the-counter hearing aids to have user-adjustable volume control, and simplifying the wording of the product label. Additionally, under the final rule, the FDA will not require age verification for the sale of over-the-counter hearing aids and will not require over-the-counter hearing aids to be self-adjusting devices.
Manufacturers of hearing devices sold before October 17, 2022 (i.e. the effective date of the final rule) will have 240 days to comply with the new or revised requirements. For hearing devices that have not been released for sale before the effective date, manufacturers must comply with the new or revised requirements before placing their devices on the market, including obtaining pre-marketing notification. marketing, if applicable.
The FDA’s change in hearing aid requirements for people with perceived mild to moderate hearing loss will greatly facilitate access to hearing aids.
Foley is here to help you deal with the short- and long-term impacts as a result of the FDA’s final rule. We have the resources to help you navigate these important legal considerations related to business operations and industry-specific issues. Please contact the authors, your Foley relationship partner, or our healthcare practice group with any questions.