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.

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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.

1)  Warnings and additional information regarding your hearing health.

  • Warning against use in people younger than 18
  • Symptoms suggesting perceived mild to moderate hearing loss.

This hearing aid is for adults with signs of mild to moderate hearing loss. How do you know if you have this?

  • You have trouble hearing speech in noisy places
  • You find it hard to follow speech in groups
  • You have trouble hearing on the phone
  • Listening makes you tired
  • You need to turn up the volume on the TV or radio, and other people complain it’s too loud

Some people with hearing loss may need help from a hearing healthcare professional. How do you know if you need to see one?

  • You can’t hear speech even if the room is quiet
  • You don’t hear loud sounds well, for example, you don’t hear loud music, power tools, engines, or other very noisy things

If your hearing loss makes it hard to hear loud noises, this hearing aid may not be your best choice without help from a professional. If this hearing aid does not help you enough, ask for help from a hearing healthcare professional.

  • “Red flag” conditions.

WARNING: When to See a Doctor

If you have any of the problems listed below, please see a doctor, preferably an ear-nose-throat doctor (an ENT).

  • Your ear has a birth defect or an unusual shape. Your ear was injured or deformed in an accident.
  • You saw blood, pus, or fluid coming out of your ear in the past 6 months
  • Your ear feels painful or uncomfortable
  • You have a lot of ear wax, or you think something could be in your ear
  • You get really dizzy or have a feeling of spinning or swaying (called vertigo)
  • Your hearing changed suddenly in the past 6 months
  • Your hearing changes: it gets worse then gets better again
  • You have worse hearing in one ear
  • You hear ringing or buzzing in only one ear
  • Notice of contact information.

This information and other labeling, including the user instructional brochure, are available on the internet at: [weblink to all labeling and any additional resources]

You may also call [telephone number] or write to [email address] or [postal address] to request a paper copy of this information and other labeling. 

  • Manufacturer’s return policy.

Manufacturer’s return policy: [succinct, accurate statement of return policy or absence of return policy]

2)  Whether the device is used or rebuilt.

3)  The words “OTC” and “hearing aid” are prominently displayed on the packaging. 

4)  Information regarding the type and number of batteries, and whether batteries are included.

5)  Whether a mobile phone or remote-control device is necessary to control the OTC hearing aid.

Please note, statements such as “FDA Registered” and “FDA Certified” medical devices, and the use of an FDA logo on an OTC hearing aid package labeling may be misleading. For more information, please refer to Are There “FDA Registered” or “FDA Certified” Medical Devices? How Do I Know What Is FDA Approved?, and FDA Logo Policy.

Additionally, the FDA’s OTC hearing aid regulations do not require manufacturers to provide a warranty. However, you should understand the terms of any applicable return or warranty period from the manufacturer, so you have enough time to test your device in different environments and allow yourself time to adjust to the new sounds in different listening environments.

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

It takes time and practice to get used to wearing hearing aids. You should wear your hearing aids regularly and become familiar with their features. You may have to practice putting the hearing aids in and taking them out, as well as learn to adjust the program settings in different listening environments. If you feel you are not receiving benefit from your OTC hearing aids, consider seeking a consultation with a hearing health care professional.

Report Problems with OTC Hearing Aids to the FDA

Tell the FDA about any injuries, malfunctions, or other adverse events related to medical devices, including OTC hearing aids, through the online MedWatch form or by calling 1-800-FDA-1088. Submit the information to the FDA as soon as possible after the event. Adverse events may include ear canal or outer ear skin irritation, injury from the device (like cuts, scratches, or burns from an overheated battery), pieces of the device lodged in your ear canal, or sudden increased severity in hearing loss with device use.

Report Allegations of Regulatory Misconduct

An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices, including OTC hearing aids, may be doing so in a manner that violates the law. Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation. Instructions and online forms are available at Reporting Allegations of Regulatory Misconduct.

OTC Hearing Aid Resources

The following resources may help you learn more about OTC hearing aids.