WASHINGTON ( Associated Press) – Millions of Americans will be able to buy hearing aids without a prescription later this year under a long-awaited rule finalized Tuesday.
The Food and Drug Administration (FDA) said the new rule removes bureaucratic hurdles by creating a new category of hearing aids that does not require a medical exam, prescription or other evaluation. The devices will be sold online or in pharmacies and other retail stores.
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that about 30 million adults could benefit from devices, but only a fifth of people with hearing problems currently use them.
“Today’s decision by the FDA represents an important milestone in making hearing aids more accessible and cost-effective,” Health Secretary Javier Becerra said in a statement to reporters.
The measure, proposed last year by the FDA, goes into effect in October.
It follows years of lobbying by medical experts and consumer advocates to make the devices less expensive and easier to obtain.
Cost is still a major hurdle. Americans can pay more than $5,000 for a hearing aid. Insurance coverage is limited and the Medicare program does not pay for equipment, only diagnostic tests.
Brian Dees, White House economic advisor, said, “The need to visit an expert was not only a burden and inconvenience for many consumers, but also created a competitive barrier.”
Dees cited government estimates that Americans could ultimately save up to $2,800 per pair. But FDA officials cautioned against predicting the magnitude of the savings or when they would come, noting that much will depend on when manufacturers launch their products and the prices they set.
“It’s very difficult to predict what and when we’ll see,” said Dr. Jeffrey Shuren, chief of medical devices for the FDA.
He said officials expect competition to increase as well as new products from existing manufacturers in the sector.
The new condition will not apply to devices with more severe hearing loss, which will continue to be prescription-only.
For years, electronic device companies have produced low-cost “personal sound amplification” devices, but they are not subject to FDA review and federal regulations prevent them from being promoted as hearing aids. The new rule clearly states that these devices are not a substitute for agency-approved prosthetics.
The FDA said it changed several parts of its initial proposal in response to public comments, including to clarify how the rule would affect regulations in states.
Tuesday’s announcement follows pressure from medical committees and Congress, which in 2017 directed the agency to draw up a plan for nonprescription hearing aids.