On August 16, 2022, the FDA issued a rule establishing “over-the-counter hearing aids to improve access to safe, effective, and affordable hearing aids for millions of Americans”. These hearing aids can be purchased by patients with perceived mild to moderate hearing loss without the need to see a prescriber.

 What to Know About OTC Hearing Aids

1) OTC hearing aids are only available for adults over the age of 18 years – children will still require a prescription.

• The purchaser of the hearing aid must also be 18 years of age or older.

2) OTC hearing aids are self-fit and do not have to be purchased from a licensed seller.

• The purchaser will be able to fit the hearing aid themselves and be able to control and adjust the device, as needed.

• OTC hearing aids will be less expensive than prescription hearing aids – a pair of prescription hearing aids typically cost over $5000 on average. The American Academy of Audiology predicts that OTC hearing aids will cost between $300-$600.

3) The FDA amended the original proposed rule from October 2021 to ensure that OTC hearing aids are safe and effective – these changes include lowering maximum sound output, revising insertion depth, adding user-adjustable volume control, simplifying package wording for the consumer, and specifying performance and device design requirements.

• This revision ensures that the OTC hearing aid products will come with information that can be understood by most patients as well as prevent damage to the patient’s ears if used inappropriately.
  

4) Hearing aids and personal sound amplification products (PSAPs) are NOT the same things – hearing aids are regulated medical devices for people with hearing problems. PSAPs amplify sound for people with normal hearing.

• The FDA will issue a regulatory requirement to help consumers distinguish between the two.

5) After their publication in the Federal Register on August 16, 2022, the policies regarding OTC hearing aids will go into effect in 60 days, and manufacturers have 240 days to comply with the new or revised requirements, and new products must comply before being put out on the market.

6) After their publication in the Federal Register on August 16, 2022, the policies regarding OTC hearing aids will go into effect in 60 days, and manufacturers have 240 days to comply with the new or revised requirements, and new products must comply before being put out on the market.

• Pharmacists are trained to educate patients on how to use other medical devices such as inhalers or insulin pens; hearing aids will now be added to that list. There are some training programs already created such as this course offered by the University of Pittsburgh: https://pittprofessional.catalog.instructure.com/courses/champ

Preparing to Promote Your OTC Hearing Aids 

If over-the-counter hearing aids are something you think you would like to offer at your pharmacy, you might want to start thinking about how you will inform patients about the availability. Here are a few ideas on how you can promote this new offering:

• Add a page or banner to your pharmacy website 
• Spread the word on social media 
• Inform your patients with automated texts
• Create an IVR greeting or on-hold message

Concluding Thoughts on OTC Hearing Aids

In conclusion, this ruling will provide nearly 30 million Americans access to an affordable solution for mild to moderate hearing loss. Pharmacies will now have the opportunity to help patients detect and treat early signs of hearing loss as well.

Photo 144187010 © Andras Csontos | Dreamstime.com