Hearing aids will soon be sold over the counter and without a prescription, the Biden administration announced Tuesday. A new final rule from the Food and Drug Administration created a new category for over-the-counter hearing aids—one that won’t require exams or expensive fittings. The devices could be in stores in mid-October.
This rule may come as a relief to the millions of people in the United States who have some level of hearing loss. The new landscape could provide an easy way for headphone makers and other tech companies to start selling devices like headphones that act as hearing aids – a market that many big companies have been eyeing for years.
Over-the-counter hearing aids have been in the works for years: Congress first passed legislation to allow over-the-counter sales in 2017, but the process of actually putting the rules into action progressed slowly . President Joe Biden issued an executive order last year calling on the FDA to put the rules in place beforehand, and the agency drew up a plan in the fall. Hearing aid industry groups pushed back. The new final rule is the final step in the process — it will go into effect in 60 days, and hearing aids could be available in drugstores as early as October.
“Today’s action by the FDA is an important milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Javier Becerra said in a statement.
Some of that access may come through headphone companies. The line between headphones and hearing aids has already blurred over the years. In 2018, Bose won the first FDA approval for a “self-fitting” hearing aid that could in some cases be sold directly to consumers. (it was not technically Over the counter because there were still some state-level laws that restricted the sale of hearing aids to licensed hearing aid dispensers.) Bose began selling hearing aids in 2021, but the company called off that program and ended this spring. in closed its health services department.
Headphone company Jabra also makes hearing aids, and its Enhance Plus wireless earbuds are marketed as “hearing-enhancing.” Apple is reportedly considering entering the hearing aid business — and the AirPods Pro already has a “Conversation Boost” feature that makes it easier to hear voices. The new Bluetooth audio standards also include support for hearing aids.
Audiologists, for their part, voice concerns about over-the-counter hearing aids, saying a professional evaluation is still important for people with hearing loss. And it’s still unclear which headphones and tech companies, if any, are planning Take advantage of this new choice of hearing aids. It could certainly lead to further advances in hearing tech from companies already making hearing aids. For example, Eargo was at CES this year, and other companies have presented at trade shows in the past.
But with this new rule, hearing aids have become another area where gadgets overlap with medical devices – linking things like heart rate and blood oxygen levels as bodily functions by tech companies.