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FDA approves over-the-counter hearing aids

Over-the-counter hearing aid sales will soon be a reality in the US. The U.S. Food and Drug Administration has issued a final rule allowing the sale of hearing aids for mild to moderate impairment without the need for an exam, prescription or audiologist accessories. The measure is expected to go into effect in mid-October, when you should see assistive devices arrive in brick-and-mortar retail stores.

For anyone with severe hearing loss or under the age of 18, you still need a prescription. The FDA also established design and performance requirements for over-the-counter drugs and adjusted prescribing rules to ensure “consistency.” The final rule is a response to public and industry feedback, including requirements for reduced maximum sound output, user volume controls, and ear canal depth limits.

Congress first passed laws requiring over-the-counter hearing aids in 2017 to reduce healthcare costs, improve access and spur competition. In theory, as access and technology improve, you’ll see more and more people wearing these devices. However, the FDA has until October 2021 to propose the necessary rules for full implementation of wearables.

It may take a while to have a wide selection, but here or in the works. For example, Lexie recently started selling the $899 B1, which uses technology from Bose’s reportedly defunct hearing aid division. Companies like Jabra jumped in early too. The prices are not trivial, but they are relatively cheap when the historical cost of AIDS before insurance is thousands of dollars.

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