The Biden administration announced on Tuesday that hearing aids will soon be sold over the counter and without a prescription. A new rule from the Food and Drug Administration (FDA) created a new category for over-the-counter hearing aids. The devices will reach stores as early as mid-October.
This move has increasingly become more important, as hearing loss is expected to rise dramatically in the coming decades. Almost 630 million people worldwide will have a hearing disability, The World Health Organization (WHO) warns that by 2030. By 2050, that could jump to 900 million, due to regular exposure to loud sounds at work and in people’s personal lives such as listening to music in earphones.
Tens of millions of Americans with hearing loss could benefit from the rule. Those with severe hearing loss and children under the age of 18 will still require a prescription from an audiologist. Headphone makers and other tech companies may also find it easier to sell headphones that function as hearing aids under the new landscape.
Legislation allowing over-the-counter sales was first passed by Congress back in 2017, but the process of actually implementing the regulations moved slowly. After President Biden issued an executive order last year, the FDA came up with a plan in the fall to implement the rules. The new final rule is the last step in the process which will go into effect in 60 days, and hearing aids will soon be available in drug stores as early as October.
Health and Human Services Secretary Xavier Becerra stated, “today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible”.
Some of that access could come in from headphone companies. FDA approved BOSE application for its “self-fitting” hearing aid in 2018. Bose first sold hearing aids in 2021, but the company stopped that program this spring and shut down its healthcare division.
The Jabra Enhance Plus wireless earbuds are marketed as “hearing-enhancing.” According to reports, Apple has also considered entering the hearing aid market with AirPods Pro already having a “Conversation Boost” feature. A new Bluetooth audio standard now supports hearing aids as well.
They won’t be quite as cheap, but they will likely be less than today’s hearing aids, which can be priced as much as $5,000 and very often aren’t covered by insurance. The price of those devices could be cut in half once the rule takes effect, said FDA.
People with hearing loss should still receive a professional assessment before buying over-the-counter hearing aids, according to audiologists but with this new rule, hearing aids have yet to become another area where gadgets overlap with medical devices.