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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
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  3. Products and Medical Procedures
  4. Home Health and Consumer Devices
  5. Consumer Products
  6. Hearing Aids
  1. Consumer Products

Hearing Aids

UPDATE - May 3, 2023:  The FDA published a new web page with details about over-the-counter (OTC) Hearing Aids: What You Should Know before and after buying an OTC hearing aid.

Drawing of Hearing Aid

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 what you should know before and after buying OTC hearing aids. 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.

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
Intended Users
  • People 18 years and older
  • For those with perceived mild to moderate hearing loss
  • People of any age, including those younger than 18 years
  • For people with any degree of hearing loss, including severe
 People of any age with normal hearing to amplify sounds in certain environments
Conditions for Sale
  • Purchaser must be 18 years or older
  • No medical exam
  • No prescription
  • No fitting by audiologist
  • No need for licensed seller
  • Prescription needed
  • Must purchase from licensed seller in some states
 No applicable FDA requirements regarding conditions for sale

Related Information

Hearing Loss 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. 



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