FDA and OTC Hearing Aids

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

Frequently asked questions

It all began with a simple idea fueled by a deep passion. As a small business, we pride ourselves on personal attention and dedication to every detail. Our approach is rooted in quality and integrity, ensuring that everything we do reflects our commitment to excellence.

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.

Example answer to the question. Feel free to customize this content with the actual information you want to provide.

.

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.

.

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. 

 

.

Beyond the ordinary

This is where our journey begins. Get to know our business and what we do, and how we're committed to quality and great service. Join us as we grow and succeed together. We're glad you're here to be a part of our story.