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 olderFor those with perceived mild to moderate hearing loss | People of any age, including those younger than 18 yearsFor 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 olderNo medical examNo prescriptionNo fitting by audiologistNo need for licensed seller | Prescription neededMust purchase from licensed seller in some states | No applicable FDA requirements regarding conditions for sale |
Source: https://www.fda.gov/medical-devices/consumer-products/hearing-aids