Hearing aids may soon be sold without a prescription, Biden’s administration announced on Tuesday. a new last rule of the Food and Drug Administration created a new category for over-the-counter hearing aids — which would not require an exam or expensive fitting. The devices could be in stores as early as mid-October.
The rule could come as a relief to the tens of millions of people in the United States with some hearing loss. The new landscape could also offer headphone makers and other tech companies an easier way to start selling headphone-like devices that act as hearing aids — a market that many large companies have been eyeing for years.
Over-the-counter hearing aids have been in the works for years: Congress first passed legislation in 2017 to allow over-the-counter sales, but the process of actually putting the regulations into practice has been slow. President Joe Biden has a executive order last year, the FDA called for the rules to be enacted already, and the agency released 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,” said Xavier Becerra, Secretary of Health and Human Services. pronunciation.
Some of that access may come through headphone companies. The line between headphones and hearing aids has been blurring for years. In 2018 Bose achieved the first FDA approval for a “self-adjusting” 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 restricting sales of hearing aids to licensed hearing aid dispensers.) Bose began selling hearing aids in 2021, but the company discontinued that program and closed its health division this spring.
Headphone company Jabra also makes hearing aids and the Enhance Plus wireless earbuds are marketed as ‘hearing-enhancing’. Apple has reportedly been considering entering the hearing aid industry – and AirPods Pro already have a “Conversation Boost” feature that makes it easier to hear voices. New Bluetooth audio standards also include hearing aid support.
Audiologists, for their part, have expressed concerns about over-the-counter hearing aids, saying that a professional assessment still important for people with hearing loss. And it’s still not clear which headphone and tech companies plan to do that take advantage of this new hearing aid option. It could certainly lead to more advancements in hearing technology from companies that already make hearing aids. Eargo, for example, was at CES this year and other companies have presented themselves at the fair in the past.
But with this new rule, hearing aids become yet another area where gadgets overlap with medical devices — merging things like heart rate and blood oxygen levels as bodily functions used by tech companies.
