In 2017, Congress ordered the Food and Drug Administration (FDA) to develop rules that would allow and encourage OTC sales of hearing aids.

The intent of such a move was to boost competition in a market that has seen consolidation amongst manufacturers along with state licensing laws that require hearing aid purchases to go through audiologists or other hearing professionals. In the meanwhile, device-makers were also acquiring hearing professionals’ practices. Suffice to say, these conditions have led to very little price competition and increased costs for one to obtain hearing aids.

Covid delayed any action taken by the FDA and President Biden subsequently issued an Executive Order in July 2021 that included 72 initiatives to address price competition in our nation. One of those initiatives called on the FDA to make hearing aids available over the counter, without a prescription.

Today, the FDA final rule becomes effective to clear the way for OTC purchase of hearing aids. According to the federal register, hearing loss affects an estimated 30 million people in the United States and only one fifth seek treatment due to the previous barriers we mentioned. The FDA is estimating that the final rules could lower the average cost of hearing aids by as much as $3,000 per pair.

The White House released a statement today which included an announcement that Walgreens, CVS and Walmart will sell OTC hearing aids starting today. Walgreens and Walmart are asserting that the cost savings for the OTC hearing aids compared to prescription hearing aids will be in the thousands of dollars range.

It is important to note that OTC hearing aids are designed for those with mild to moderate hearing loss. OTC hearing aids will require the user to set up the device on their own, with variable levels of support. Experts have weighed in with helpful advice as this new product hits the market. Most notably, that advice includes purchasing only hearing aids marked as FDA approved, comparing return policies, looking for “self-fitting” labeled devices, and checking to understand what is needed to properly install the device (i.e. a smartphone, app, computer, etc).

We found a tip sheet for purchasing OTC hearing aids on this site sponsored by the Hearing Loss Association of America.

For those wondering if OTC hearing aids will be a qualifying expense using a healthcare FSA or HSA, the answer is not entirely clear, but likely to be eligible in the same way that non-prescription eyeglasses are covered. FSA participants should contact their FSA vendor for confirmation while HSA account holders should consult with their tax advisor.


Let your IMA Benefits team know if you have any questions.  We review affordability every year with our applicable large employer (ALE) clients and are happy to assist as you strategize for your plan year beginning in 2022.

IMA will continue to monitor regulator guidance and offer meaningful, practical, timely information.

This material should not be considered as a substitute for legal, tax and/or actuarial advice. Contact the appropriate professional counsel for such matters. These materials are not exhaustive and are subject to possible changes in applicable laws, rules, and regulations and their interpretations.