OTC Hearing Aids

In a historic move on August 17, 2022, the Food and Drug Administration (FDA) issued a new rule allowing over-the-counter (OTC) hearing aids to be sold for adults with mild-to-moderate hearing loss. 

This ruling came after President Joe Biden's executive order in July 2021, directing the US Department of Health and Human Services to consider allowing hearing aids to be sold over the counter. The FDA's decision ensures the safety and effectiveness of OTC hearing aids while promoting innovation and competition in the hearing aid technology market.

To clarify the differences between hearing aids and personal sound amplification products (PSAPs), the FDA also issued final guidance on regulatory requirements for these devices.

Implications of the New FDA Rule on OTC Hearing Aids

The FDA's new rule on over-the-counter (OTC) hearing aids is set to bring significant changes to the hearing aid industry. As a consumer, here's what you need to know about the new rule:

  • OTC hearing aids can be sold directly to consumers in stores and online without requiring a medical exam, prescription, or fitting adjustment by an audiologist.
  • The new OTC category applies to certain air-conduction hearing aids intended for individuals aged 18 and older with mild to moderate hearing impairment. Hearing aids that do not meet the OTC requirements (i.e., intended for severe hearing impairment or users under 18) remain prescription devices.
  • The rule took effect in mid-October 2022, after which consumers are able to purchase OTC hearing aids from traditional retail and drug stores.

While the new rule aims to make hearing aids more accessible and affordable, consumers must still exercise caution when purchasing OTC hearing aids. It's essential to do thorough research, read reviews, and consult with a hearing care professional before making a purchase. 

Additionally, individuals with severe hearing loss or unique hearing needs may still require a prescription hearing aid.

Valuable Facts About OTC Hearing Aids

OTC hearing aids offer an affordable option for many more people and can make the use of hearing aids more widespread.  Many users of OTC hearing aids have reported  that they always fell out of their ears, never fit right, made everything louder not clearer. 

Professionally fit hearing aids are likely to provide better results than OTC hearing aids since they are prescribed to meet the wearer's specific needs and level of hearing loss. 

OTC hearing aids, on the other hand, do not offer the same level of customization and are not programmed to the wearer's specific hearing loss.

  • The FDA already regulates hearing aids as medical devices; however, OTC hearing aids are a newly regulated category of devices designed for adults with perceived mild to moderate hearing loss.
  • Proper testing is a necessary first step to check for the usability of OTC hearing aids since studies have shown that self-assessment for the degree of hearing loss is often underestimated by younger adults or overestimated by older adults.
  • While online hearing screenings can be convenient, they are not a substitute for a formal audiological exam. An audiological exam is more comprehensive, including checks for bone conduction, use of audiometric masking, test for word recognition, and evaluation of a comprehensive set of audio frequencies. 

Ken Pruyn from The Hearing Professionals, recommends a comprehensive hearing evaluation before considering any hearing device. This hearing test is free and lasts about an hour. 

The test will help diagnose the problem more accurately and determine if hearing aids are needed for one or both ears. While the final decision on which hearing aid to purchase is always yours, a hearing evaluation will provide valuable information to help you make an informed decision.

Who OTC Hearing Aids Are Not Designed For

OTC hearing aids are not recommended for individuals with moderate to profound hearing loss,  it is highly recommended to consult a qualified, Hearing Healthcare Professional.  

This is due to the fact that individuals with moderate to profound hearing loss may have difficulty hearing conversations, ambient sounds, and extremely loud sounds. 

They may hear speech but may have trouble discerning the words in noisy environments, leading to the need for parts of a conversation to be repeated. 

Additionally, they may not be alerted by small or loud sounds in their environment and may only feel the vibrations from extremely loud sounds. 

A Hearing Professional, can provide a more comprehensive evaluation and recommend hearing aids that are specifically designed to meet an individual's needs. Once you have a complete evaluation, The Hearing Professionals can help you select the best hearing aid option for you.

Benefits of OTC Hearing Aids

According to the National Institute on Deafness and Other Communication Disorders, hearing loss affects tens of millions of adults in the United States, significantly impacting their quality of life and contributing to high healthcare costs. 

Untreated hearing loss can lead to isolation and serious conditions, such as 

  • Depression
  • Anxiety
  • Low self-esteem
  • Dementia
  • Reduced mobility
  • Falls

Despite the benefits of hearing aids, only one in four adults who could benefit from them has ever used them. Making hearing healthcare more accessible and affordable is a public health priority, especially as the number of older adults in the U.S. grows.

Experts in science, technology, and hearing healthcare have been working to find safe and effective ways to improve access to hearing healthcare for adults. OTC hearing aids are a big step in this direction. 

With OTC hearing aids, individuals can access affordable and readily available hearing aids without the need for a prescription or medical evaluation. This increased access can improve their quality of life, reduce healthcare costs, and promote overall well-being.

OTC Hearing Aids in Massachusetts

Ken Pruyn is a Licensed Hearing Instrument Specialist with over 14 years of experience. He is passionate about helping you hear clearly. Ken prides himself on taking the time to find the hearing solution that works best for you. 

If you need OTC hearing aids, Ken can help you find a hearing solution that works for you.

You can request an appointment online or call us at (508) 794-3620 to arrange an in-office appointment at any of our eight Massachusetts offices: Framingham, Marlborough, Concord, Waltham, Newton, Dedham, Quincy, and Hingham

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