FDA greenlights over-the-counter hearing aids

Over-the-counter hearing aid sales should soon become a practical reality in the US. The Food and Drug Administration has issued a final rule allowing the sales of hearing aids for mild-to-moderate impairment without requirements for exams, prescriptions or audiologist fittings. The measure is expected to take effect in mid-October, when you should see aids reach physical retail stores.

You’ll still need a prescription for severe hearing loss, or for anyone under 18. The FDA has also set design and performance requirements for over-the-counter aids, and has tweaked rules for prescriptions to ensure “consistency.” The definitive rule comes in response to public and industry feedback, including lower maximum sound output, a requirement for user volume control and canal depth limits.

Congress first passed laws requiring over-the-counter hearing aids in 2017 in a bid to lower healthcare costs, improve access and spur competition. In theory, you would see more people wearing the devices as access and technology improve. However, the FDA didn’t propose the necessary rule to fully implement the wearables until October 2021.

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It could be awhile before there’s a wide range of choices, but there are already offerings here or in the works. Lexie, for instance, recently began selling the $899 B1 using technology from Bose’s reportedly defunct hearing aid division. Companies like Jabra have also leaped in early. The prices aren’t trivial, but they’re relative bargains when aids have historically cost thousands of dollars before insurance.