October 19, 2021 – Status on Over-the-Counter (OTC) Hearing Aids
The FDA Reauthorization Act of 2017 (FDARA) details certain requirements to establish a category of over-the-counter (OTC) hearing aids and the kinds of regulatory requirements that will apply to them. To establish the OTC category and realign other regulations for hearing aids, the FDA published proposed regulations for public comment and will eventually publish final regulations, taking public comments into account.
At this time, there are no products that can be legally marketed as OTC hearing aids within the meaning of section 520(q) of the FD&C Act, as amended by FDARA. Currently, hearing aids continue to be restricted devices, for which sales must follow applicable federal and state requirements. The FDA has published a letter to clarify the status of these products, which still represents FDA’s current thinking. Of note, certain states do permit direct-to-consumer marketing of hearing aids (for example, through internet sales), and these may be an option for you depending on the state in which you live.
Having trouble hearing? An estimated 38 million people in the United States have some degree of hearing loss. Hearing loss can have a negative effect on communication, relationships, school or work performance, and emotional well-being. However, hearing loss doesn't have to restrict your daily activities. Properly fitted hearing aids and aural rehabilitation can help in many listening situations. Aural rehabilitation is the use of techniques to identify and diagnose hearing loss and implement therapies for patients who are hard of hearing, which often involves the use of hearing aids. Aural rehabilitation helps a person focus on adjusting to their hearing loss and the use of their hearing aids. It also explores assistive devices to help improve communication. Most people who are hearing-impaired will need two hearing aids because both ears are often affected by hearing loss, though some people may only need one hearing aid.
This site includes information on the difference between hearing aids, which are intended for use by people with hearing loss, and personal sound amplification products (PSAP), which are intended for consumers with no hearing loss who want to make environmental sounds louder, such as for recreational activities like birdwatching or hunting. While the FDA regulates hearing aids as medical device, such PSAPs are not medical devices.
The President's Council of Advisors on Science and Technology (PCAST), and the National Academies of Sciences, Engineering and Medicine (NASEM) issued reports recommending ways to improve access to and affordability of hearing aids. The FDA considered these recommendations along with input from the public and has issued the "Immediately in Effect Guidance Document: Conditions for Sale for Air-Conduction Hearing Aids" guidance document. The FDA issued this guidance to communicate that it does not intend to enforce certain conditions for sale for certain types of hearing aids when sold to users 18 years of age or older.
This site provides general information on hearing aids and their benefits, types of hearing loss, procedures to improve hearing, and a checklist of steps to remember and consider before purchasing hearing aids. This site also provides some information about other hearing products, such as PSAPs, that are not intended to improve hearing loss. This site is not intended to provide medical advice. If you have questions about your health, the best source of information is your hearing health care professional.
- Immediately in Effect Guidance: Conditions for Sale for Air-Conduction Hearing Aids (PDF - 402KB)
- The FDA engages stakeholders on opportunities to improve hearing aid usage and innovation
- Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids - Proposed Rule
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff