WASHINGTON — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The Food and Drug Administration announced that the new regulations cut red tape and created a new category of hearing aids, which don’t need a prescription or medical examination. The devices can now be purchased online, over-the-counter in pharmacies or other retail outlets.
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aid use, but only about one-fifth of people with hearing problems use the devices currently. Last October, the FDA proposed the rule . Mid-October will see the new rule go into effect.
Biden officials highlighted potential savings.
“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Xavier Becerra, said in a statement.
The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.
Cost is an issue now. Between the device itself and fitting services, Americans can pay more than $5,000 to get a hearing aid. The insurance coverage for hearing aids is limited. Medicare does not cover them.
Devices with more severe hearing loss will not be eligible for the new over-the counter status. These devices are still prescribed only.
Consumer electronic companies for years have produced lower-cost “personal sound amplification” devices, but U.S. regulations bar them from being marketed as hearing aids and they do not undergo FDA review. These devices cannot be used as alternatives to FDA-approved hearing aids. Marketers who market these devices in an inappropriate manner could be subject to fines and product seizing.
The FDA stated that it had modified several aspects of its original proposal to respond to public feedback, such as clarifying the impact of federal regulations on state hearing aid regulations.
Once the federal rule takes effect, traditional manufacturers are expected to begin selling cheaper, direct-to-consumer models. Advocates predict that the market for hearing aids will eventually mirror eye care where customers can pick between prescription or drugstore reading glasses.
Tuesday’s announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices.
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