OTC Hearing Aids: What You Should Know | U.S. Food and Drug Administration

Close to 30 million adults living in the U.S. have some degree 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 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.
  • 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 requirements 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.

Before You Buy an OTC Hearing Aid: What You Should Know

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. If you, or a friend, or family member suspect that you have a more severe or profound hearing loss, you should consult with a licensed hearing health care professional, as OTC hearing aids may not provide adequate benefit for more severe hearing losses. This is because OTC hearing aids are limited in their maximum output and may not be adequate to treat more severe hearing losses.

If you are younger than 18 years of age, you need to buy your hearing aids by prescription, and you should go to a doctor, preferably an ENT, because your condition needs specialized care.

Where You Can Buy an OTC Hearing Aid

You can buy OTC hearing aids in person at a store or through an online retailer without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.

You can also buy OTC hearing aids from a hearing health care professional (audiologist or hearing aid dispenser). These professionals can perform a hearing test and hearing aid evaluation. You can request your hearing evaluation records from your hearing health care professional and may buy your hearing aid elsewhere.

You should review the outside package labeling before you buy your OTC hearing aid. If you cannot find the outside package labeling, contact the seller or manufacturer. The OTC hearing aid regulation requires important information to be displayed on the outside package labeling for consumers to review before buying OTC hearing aids.

OTC Hearing Aid – Outside the Box Labeling
The FDA regulations require certain information on the outside the box for OTC hearing aids. Carefully review the packaging for important information. The following information is required to appear on the outside packaging.

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