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        Consumer Products

Hearing Aids

                        
                Hearing Loss
          Types of Hearing Aids
          Hearing Aid Benefits and Limitations
          Hearing Aids and Cellphones
          How to Get Hearing Aids
          OTC Hearing Aids: What You Should Know
          Other Hearing Devices and Products Home
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          Consumer Products
          Hearing AidsConsumer Products Hearing Aids
  	
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    Print**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 saleRelated Information

Establishing Over-the-Counter Hearing Aids - Final Rule
	Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products – Final Guidance
	FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans – FDA News Release
	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
	How to report problems to the FDAHearing 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.

Information on Cochlear Implants
	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

                                                                                  Content current as of:
      05/03/2023Hearing Aids                
                          

                        Hearing Loss
          Types of Hearing Aids
          Hearing Aid Benefits and Limitations
          Hearing Aids and Cellphones
          How to Get Hearing Aids
          OTC Hearing Aids: What You Should Know
          Other Hearing Devices and Products
 
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