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:

1)Are air-conduction hearing aids 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.

2)Are intended for use by people 18 years of age and older to help with perceived mild to moderate hearing loss.

3)Allow users to control the device settings and customize the device to the user’s hearing needs, through tools, tests, or software.

4)May use wireless technology or may include tests for self-assessment of hearing loss.

5)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 requirements in a store or online.

Who Can Buy an OTC Hearing Aid

If you are 18 years of age or older and believe you have perceived mild to moderate hearing loss, you can buy an OTC hearing aid in a store or online without seeing an ear-nose-throat (ENT) doctor, or a licensed hearing health care professional (audiologist). Please note that OTC hearing aids are intended only for perceived mild to moderate hearing loss, and NOT for the treatment of severe or profound hearing loss.
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