UPDATE - November 10, 2022: The FDA’s final rule: Establishing Over-the-Counter Hearing Aids, issued on August 17, 2022, to improve access to safe, effective, and affordable hearing aids for millions of Americans is now in effect. This action enables consumers 18 years of age and older with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.
Concurrently with issuing the final rule, the FDA also issued the final guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products on August 17, 2022. This guidance clarifies the differences between hearing aids, which are medical devices, and personal sound amplification products, which are not regulated as medical devices but help people with normal hearing amplify sounds in certain environments.
Read more in the FDA's press release: FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans.
Having trouble hearing? Close to 30 million adults 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 does not have to restrict your daily activities. Properly fitted hearing aids and aural rehabilitation can help in many listening situations. Aural rehabilitation is a patient-centered approach to reduce the impact of hearing loss on communication. Aural rehabilitation helps a person focus on adjusting to hearing loss and how to use their hearing aids. It also explores assistive listening devices to help improve communication. Most people who have hearing impairment will need two hearing aids because both ears are often affected by hearing loss. However, some people may only need one hearing aid.
This site includes information on the difference between hearing aids, which are intended for people who have hearing loss, and personal sound amplification products (PSAPs), which are intended for consumers with normal hearing. PSAPs are used to make sounds louder in certain environments, such as during recreational activities like birdwatching or hunting. PSAPs are electronic products, which are products that the FDA regulates under the Electronic Product Radiation Control Program, but they are not medical devices like hearing aids.
This site also provides general information on hearing aids, their benefits, types of hearing loss, procedures to improve hearing, and a checklist to consider before purchasing hearing aids.
The options have increased. Learn about the new category of over-the-counter hearing aids, prescription hearing aids, and how they are different from personal sound amplification products.
|Over-the-Counter (OTC) Hearing Aids||Prescription Hearing Aids (Any hearing aids that do not meet OTC requirements)||Personal Sound Amplification Products|
|Type of Product||Medical device and Electronic product||Medical device and Electronic product||Electronic product|
||People of any age with normal hearing to amplify sounds in certain environments|
|Conditions for Sale||
||No applicable FDA requirements regarding conditions for sale|
This site is not intended to provide medical advice. If you have questions about your hearing, the best source of information is a hearing health care professional.
- Establishing Over-the-Counter Hearing Aids - Final Rule
- Letter to State Officials about access to prescription hearing aids
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Final Guidance for Industry and Food and Drug Administration Staff
- Hearing Aids and Personal Sound Amplification Products: What to Know
- Electronic Product Radiation Control Program
Hearing Aids Resources
The following resources may help you learn more about hearing loss and hearing aids. The links to non-federal government organizations are provided for convenience. The FDA or the federal government do not endorse these organizations or their programs. The FDA is not responsible for the content of their web pages.
- FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans
- FDA takes steps to improve hearing aid accessibility
- Information on cochlear implants
- How to report problems to the FDA
- National Institutes on Deafness and Other Communication Disorders: Hearing Aids
- Federal Communications Commission: Hearing Aid Compatible Mobile Handsets
- American Academy of Audiology
- American Academy of Otolaryngology - Head and Neck Surgery
- American Speech-Language - Hearing Association
- Better Hearing Institute
- Access Wireless: CTIA Initiative
- Hearing Loss Association of America
- International Hearing Society