Proponents predict the hearing aid market will eventually resemble ophthalmology, where consumers can choose between drugstore reading glasses or prescription bifocals.
WASHINGTON — Millions of Americans will be able to purchase hearing aids without a prescription later this fall, under a long-awaited rule that concludes Tuesday.
The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a physical exam, prescription, and other professional evaluations. Instead, the devices are sold online or over the counter at pharmacies and 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 the use of hearing aids, but only about a fifth of people with hearing problems currently use the devices. The FDA first proposed the rule last October. The new regulation will come into effect in mid-October.
Biden administration officials highlighted the potential cost savings.
“Today’s action by the FDA represents a significant milestone in making hearing aids more affordable and accessible,” said Xavier Becerra, Secretary of Health and Human Services, in a statement.
The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and more readily available.
Cost is now a major obstacle. Between the device itself and the fitting services, Americans can pay upwards of $5,000 to get a hearing aid. Insurance coverage is very limited and Medicare does not pay for hearing aids, only diagnostic tests.
The new over-the-counter status does not apply to devices for more severe hearing loss, which remain prescription-only.
Consumer electronics companies have been making lower-cost personal sound amplification devices for years, but US regulations prohibit them from being marketed as hearing aids and they are not reviewed by the FDA. The new rule makes it clear that these devices are not alternatives to FDA-approved hearing aids. Companies that market them inappropriately can face penalties such as fines or product confiscations.
The FDA said it changed several parts of its original proposal in response to public comments, including clarifying how the federal rule will affect state hearing aid regulations.
Once the federal rule goes into effect, traditional manufacturers are expected to start selling cheaper models directly to consumers. Finally, proponents predict the hearing aid market will be similar to eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.
Tuesday’s announcement follows urging from medical committees and Congress, which directed the agency in 2017 to develop an over-the-counter hearing aid plan.
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https://www.king5.com/article/news/nation-world/over-the-counter-hearing-aids-expected-fall-2022-fda-finalizes-rule/507-f0fe78dc-ac03-4a1f-bf0d-98e46a81d4d3 Over-the-counter hearing aids could be available starting in fall