Americans can soon buy hearing aids over the counter
Hear, hear: The FDA is allowing over-the-counter purchase of hearing aids
The Food and Drug Administration cleared the way for millions of Americans to buy hearing aids over the counter — a move aimed at increasing competition, spurring innovation and driving down the cost of the pricey medical devices.
“As early as mid-October, Americans will be able to purchase more affordable hearing aids over the counter at pharmacies and stores across the country,” Biden said in a statement, adding that patients could save nearly $3,000 for a pair of hearing aids.
But it’s not so simple. It’s difficult to predict just how quickly a wide swath of manufacturers will begin selling devices over the counter and how much money Americans will save.
Yet Biden officials and a key pair of bipartisan senators are touting the long-awaited measure as a major win for consumers. Hearing aids can cost several thousand dollars and typically aren’t covered by traditional Medicare or other insurers, leaving them unaffordable to many Americans. The federal government estimates that nearly 30 million people could benefit from hearing aids, yet only about one-fifth actually use the devices.
The timeline the White House is using for PR is very optimistic.
Under the OTC final rule, manufacturers that already are marketing hearing aids have 240 days to comply with new requirements.
The likelihood that price savings will be realized by October is very low. https://t.co/uDKsD79Brp
— David Lim (@davidalim) August 16, 2022
The final regulation released yesterday was years in the making, The Post’s Eugene Scott and Katie Shepherd note.
- In 2015, outside advisers to the Obama administration made a recommendation: The FDA should create a new category of “basic” hearing aids that could be bought over the counter.
- In 2017, Congress passed legislation giving the FDA three years to propose such rules.
- But the agency failed to meet its deadlines. Biden ramped up pressure on the FDA in an executive order signed in July 2021 — and it took another year before the rules were finalized.
Specifically … The change allows adults with mild to moderate hearing loss to buy the devices in stores and online without having a prescription or a medical examination. Such a change is expected to particularly help older adults, poor Americans and those living in rural areas where access to audiologists may be limited.
“The downside — if there’s a downside — is that people may choose to purchase a hearing aid without going to see a hearing professional,” said Tricia Neuman, a senior vice president at the Kaiser Family Foundation. “And they may not be able to get a hearing aid that fits them well, that can be adjusted over…
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