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FDA is proposing to establish an over-the-counter category of hearing aids to promote the availability of additional kinds of devices that address mild to moderate hearing loss, and proposing related amendments to the current hearing aid regulations, the regulations codifying FDA decisions on State applications for exemption from preemption, and the hearing aid classification regulations.

Statement of Need:

Hearing loss affects an estimated 30 million people in the United States and can have a significant impact on communication, social participation, and overall health and quality of life. However, only about one-fifth of people who could benefit from a hearing aid seek intervention. Several barriers likely impede the use of hearing aids, and FDA is proposing rules to address some of these concerns.

Summary of the Legal Basis:

The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) establishes a comprehensive system for the regulation of devices intended for human use, and hearing aids are subject to those provisions. Furthermore, the FDA Reauthorization Act of 2017 (Pub. L. 115-52, 131 Stat. 1005, 1066) directs FDA to establish by regulation a category of over-the-counter hearing aids. This rulemaking establishes requirements for the safe and effective use of hearing aids, including for the over-the-counter category of hearing aids.  

Alternatives:

FDA must establish the category of over-the-counter hearing aids as well as requirements that provide for reasonable assurance of safety and effectiveness of these hearing aids. However, FDA will consider different specific options to maximize the health benefits to hearing aid users while minimizing the economic burdens of the final rules.

Anticipated Costs and Benefits:

FDA expects benefits of the rule to include cost savings to consumers who wish to buy lower-cost hearing aids, in part by enabling consumers to cross-compare and purchase the devices more easily. Other benefits may include improving health equity, especially for Americans living in rural areas, those with limited mobility, or those with limited means. Individual benefits may include improved health outcomes, and therefore improved social and economic participation. FDA expects costs to include those costs to manufacturers for changing labeling and updating existing processes.

Risks:

None