The Food and Drug Administration has issued a final rule establishing a new category of over-the-counter hearing aids.  This will allow people with ‘mild to moderate’ hearing loss to buy hearing aids directly from stores or online retailers.  Consumers will not need an exam, prescription or a fitting by an audiologist. The rule should make hearing aids affordable for seniors on fixed incomes who may not be able to afford the high cost of prescription devices – which run in the thousands of dollars per pair. (Traditional Medicare does not yet cover these costs.)

“For millions of Americans, hearing aids and the doctor’s visit to get them prescribed are too expensive. In the executive order I issued last year to increase competition in key industries and lower costs, I called on the FDA to finally make hearing aids available over the counter. Today, the FDA is doing just that.” – President Biden, 8/16/22

President Biden’s executive order required the FDA to allow hearing aids to be sold over the counter and gave the agency 120 days to accomplish it. Congress passed legislation in 2017 empowering the FDA to create a category of OTC hearing aids, but it was not fully implemented until now. “Consumers could see OTC hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect,” says the FDA.

The National Committee to Preserve Social Security and Medicare has long advocated for over-the-counter hearing aids, especially because hearing care is so crucial to seniors’ overall health.

“As someone who suffers from hearing loss, I understand what this means for seniors’ health – and their pocketbooks.  While we hope that Medicare will eventually cover hearing aids, the new rule allowing OTC hearing aids is a common sense, compassionate measure that will improve seniors’ access to quality devices.” – Max Richtman, President of the National Committee to Preserve Social Security and Medicare

Prescription hearing aids can cost as much as $2,500 each (or $5,000 a pair).  The hefty price tag can be a severe strain for seniors living on fixed incomes, especially since Medicare does not cover hearing aids. That’s why some 70% of Americans between age 65 and 84 with hearing loss are not using hearing aids.  They simply cannot afford to.

The new generation of OTC hearing aids will retail for a fraction of the prescription price:

“By opening the market to OTC aids, manufacturers of consumer electronics — from giants such as Apple and Samsung to small startups — could enter the hearing aid space and sell directly to consumers… [at a retail price] between $150 and 299.” – The Hill Newspaper

Imagine being able to buy high-quality hearing aids at your local pharmacy or grocery store for as little as $150, bypassing the time-consuming and expensive process of acquiring them from an audiologist.  Of course, those with more serious hearing impairment will and should continue to seek prescription hearing aids through a specialist.

This is not just a matter of personal cost.  It’s a public health issue. Hearing loss is a gateway to other potential medical problems – including fatigue, stress, depression and memory loss.  Access to affordable, high-quality OTC hearing aids means that millions of seniors will likely be able to hear better and stay healthier.