Many people experience hearing loss and related hearing issues. To date, to get a hearing aid, people needed a prescription and to see a licensed hearing aid specialist in order to be properly diagnosed and fitted for a hearing aid. Now, as outlined below, the U.S. Food and Drug Administration (FDA or Agency) has issued a final rule that changes the requirements so that no prescription is necessary for people with perceived mild to moderate hearing loss. The result will be that such people can have more ready access to hearing aids.
On August 16, 2022, the FDA finalized a long-awaited rule establishing a new over-the-counter (OTC) hearing aids category. This final rule only applies to individuals who are age 18 and older with perceived mild to moderate hearing loss. The final rule will take effect on October 17, 2022.
The FDA estimates that approximately 30 million people in the U.S. are affected by hearing loss, but only about one-fifth of this population seek intervention. According to the FDA, the final rule aims to encourage competition and facilitate the sale of OTC hearing aids in an effort to improve access to these devices for individuals with perceived mild to moderate hearing loss.
Under the final rule, consumers with perceived mild to moderate hearing loss will be able to purchase hearing aids directly online or in retail stores without a medical exam, prescription, or a fitting adjustment by a licensed audiologist. Hearing aids that do not meet the OTC regulatory requirements (e.g., intended for severely hearing impaired or for individuals younger than age 18) will be deemed prescription devices by the Agency.
The final rule will require OTC hearing aids to comply with regulatory requirements under 21 C.F.R. § 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 C.F.R. Part 820. Furthermore, the final rule amends existing rules that apply to prescription hearing aids, repeals the conditions for sale for hearing aids, and addresses preemption issues including state consumer protections requirements.
In response to comments submitted to the proposed rule issued last October, FDA made several notable changes in the final rule. These changes include lowering the maximum sound output, revising the insertion depth limit in the ear canal, requiring that all OTC hearing aids have a user-adjustable volume control, and simplifying the wording on the product labeling. Additionally, under the final rule, FDA will not require age verification for the sale of OTC hearing aids and will not require OTC hearing aids to be self-fitting devices.
Manufacturers of hearing aids sold prior to October 17, 2022 (i.e., the effective date for the final rule) will have 240 days to comply with the new or revised requirements. For hearing aids that have not been offered for sale prior to the effective date, manufacturers must comply with the new or revised requirements before marketing their devices, including obtaining a premarket notification if applicable.
FDA’s change in hearing aid requirements for people with perceived mild to moderate hearing loss will make it significantly easier to get access to hearing aids.
Foley is here to help you address the short and the long term impacts in the wake of FDA’s final rule. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.