Hearing aids will soon be available over the counter and without a prescription, the Biden administration announced Tuesday. A new final rule of the Food and Drug Administration has created a new category for over-the-counter hearing aids – which would not require costly examination or adjustment. The devices could be in stores as early as mid-October.
The rule could be a relief for the tens of millions of people in the United States suffering from some level of hearing loss. The new landscape could also give headphone makers and other tech companies an easier way to start selling headphone-like devices that work like hearing aids — a market that many big companies have been watching for years.
Over-the-counter hearing aids have been in the works for years: Congress passed an initial law in 2017 to allow over-the-counter sales, but the process of implementing the regulations has moved slowly. President Joe Biden released a Executive Decree last year calling on the FDA to already have the rules in place, and the agency released a plan in the fall. Hearing aid industry groups pushed back. The new final rule is the last step in the process – it will come into effect in 60 days and hearing aids could be available in pharmacies as early as October.
“Today’s action by the FDA represents an important step in making hearing aids more cost-effective and more accessible,” Health and Human Services Secretary Xavier Becerra said in a statement. statement.
Some of that access could come from headset companies. The line between headphones and hearing aids has been blurring for years. In 2018, Bose was awarded the first FDA clearance for a “self-adjusting” hearing aid that could be sold directly to consumers in some cases. (It was not technically over-the-counter because there were still state-level laws limiting hearing aid sales to licensed hearing aid distributors.) Bose began selling hearing aids in 2021, but the company discontinued this program and closed its health care division. this spring.
Headset company Jabra also makes hearing aids, and its Enhance Plus wireless headphones are marketed as “hearing-enhancing”. Apple reportedly considered getting into the hearing aid business – and the AirPods Pro already have 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, have raised concerns about over-the-counter hearing aids, saying a professional evaluation is always important for the hearing impaired. And it’s still unclear which, if any, headset and tech companies plan to take advantage of this new option for hearing aids. This could certainly lead to more advancements in hearing technology from companies that already manufacture hearing aids. Eargo, for example, was at CES this year, and other companies have exhibited at the show in the past.
But with this new rule, hearing aids become another area where gadgets overlap with medical devices – joining things like heart rate and blood oxygen levels as bodily functions trivialized by tech companies. .