Listening device for the hearing impaired
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Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized on Tuesday.
The Food and Drug Administration said the new regulations cut red tape by creating a new class of hearing aids that don’t require medical exams, prescriptions and other specialist evaluations. Instead, the devices will be sold online or over the counter at pharmacies and other retail stores.
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from using hearing aids, but only about one-fifth of people with hearing problems currently use them. The FDA first proposed the rule last October. The new rule will come into effect in mid-October.
Biden administration officials pointed to the potential cost savings.
“Today’s action by the FDA represents an important step in making hearing aids more cost-effective and more 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 obtain.
Cost is a big hurdle now. Between the device itself and the fitting services, Americans can pay over $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 will not apply to devices for more severe hearing loss, which will remain prescription-only.
For years, consumer electronics companies have produced cheap “personal sound amplification” devices, but US regulations prohibit their marketing as hearing aids and they are not subject to scrutiny. from the FDA. The new rule clarifies that these devices are not alternatives to FDA-approved hearing aids. Companies that market them improperly could face penalties, such as fines or product seizures.
The FDA said it changed several parts of its original proposal in response to public comments, including clarifying the federal rule’s impact on state hearing aid regulations.
Once the federal rule takes effect, mainstream manufacturers should start selling cheaper, direct-to-consumer models. Eventually, advocates predict the hearing aid market will resemble eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.
Tuesday’s announcement follows prompting from medical committees and Congress, which in 2017 asked the agency to introduce a plan for over-the-counter hearing aids.