FDA has finalized regulations for over-the-counter (OTC) hearing aids

FDA is defining and establishing general controls for an OTC category of hearing aids. We intend these controls to provide for reasonable assurance of safety and effectiveness for these devices, thereby protecting the public health. We also intend these controls to help improve access to and foster innovation in hearing aid technology for Americans, thereby promoting the public health. We are making several other revisions to existing regulations to align them with statutory requirements and the new OTC category.

The purpose of the FDA final rule for over-the-counter (OTC) hearing aids:

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. Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention. The use of hearing aids has been linked to, among other health benefits, reductions in the incidence or severity of cognitive decline, depression, and other health problems in older adults. Additionally, benefits of hearing aid use can include improved social participation and a better quality of life.

Besides health benefits for individuals, more-widespread adoption of hearing aids could have broader effects. By increasing social participation, hearing aids could help to improve inclusion of individuals in family, economic, civic, and religious life. Thus, reducing barriers to hearing aid access might contribute to such improvements. This could be particularly true for people of color, rural Americans, low-income individuals, and others for whom barriers to hearing aid access may be especially burdensome.

Several barriers likely impede the use of hearing aids in hearing-impaired individuals such as high cost, stigma of being perceived as old or debilitated, and value (perceived hearing benefit relative to price). FDA is finalizing rules to address some of these concerns.

Moreover, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) directs FDA to establish a category of OTC hearing aids through rulemaking, and FDARA sets forth various requirements for OTC hearing aids, including for reasonable assurance of safety and effectiveness, as well as Federal preemption provisions. In addition to protecting and promoting the public health, these rules establish the OTC category and implement the requirements of FDARA.

FDA has finalized regulations for over-the-counter (OTC) hearing aids: