What are OTC hearing aids?

Close to 30 million adults living in the U.S. have some defree of hearing loss. Despite the high number of people affected by hearing loss, only about one-fifth of those who could benefit from a hearing aid seek intervention. Using hearing aids may reduce the frequency or severity of cognitive decline, depression, and other health problems in adults. Added benefits can include improved social participation and a better quality of life. To increase the public’s access to hearing aids and improve hearing, the FDA established a new category of Over-the-Counter(OTC) hearing aids for adults 18 years of age and older with perceived mild to moderate hearing loss that went into effect on October 17, 2022.

Over-the-Counter (OTC) Hearing Aids

A hearing aid is a medical device that is intended to help with hearing loss and is worn behind or within the ear canal. The FDA regulates all hearing aids to ensure safety and effectiveness for consumers. 

OTC Hearing Aids:

• Are air-conduction hearing aid that do not require implantation or other surgical intervention. They bring amplified sound into the ear canal. Sound then moves through the eardrum and three tiny bones in the middle ear to reach the inner ear, where it’s processed and sent to the brain.
• Are intended for use by people 18 years of age and older to help with perceived mild to moderate hearing loss. 
• Allow users to control the device settings and customize the device to the user's hearing needs, through tools, tests, or software.
• May use wireless technology or may include tests for self-assessment of hearing loss. 
• Are available to consumers over-the-counter without the supervision, involvement, or prescription of a licensed health care professional. You can buy OTC hearing aids that meet the FDA's requirement in a store or online.

Within the OTC hearing aid category, consumers 18 years of age and older with perceived mild to moderate hearing loss may have the following device options:

• Legacy (traditional) and wireless hearing aids which include basic features like volume control and preset programs.
• Self-fitting hearing aids with or without a wireless feature that have greater customization through technology such as hearing tests, software, and smartphone apps. 

Note: A prescription hearing aid is any hearing aid that is not an OTC hearing aid. Prescription hearing aids are only available through a licensed hearing health care professional who can program the device to your unique level of hearing loss. These devices may be appropriate for all levels of hearing loss and for all ages based on the indications for use.