Over-The-Counter Hearing Aids Could Be Available By October After FDA OK
In a move that could make hearing aids more affordable and accessible for an estimated 30 million Americans, the Food and Drug Administration issued a final rule Tuesday allowing the devices to be sold without a prescription. President Joe Biden said that over-the-counter aids could be purchased as early as October.
Millions Of Americans Will Soon Be Able To Buy Hearing Aids Without A Prescription
Adults with perceived mild to moderate hearing impairment will be able to buy hearing aids directly from stores, pharmacies and online retailers — no prescription or doctor's appointment required — as soon as mid-October. That's thanks to a final rule issued by the U.S. Food and Drug Administration on Tuesday and set to take effect in two months, following years of campaigning by lawmakers and advocates. It creates a new category of over-the-counter hearing aids, which the Biden administration says will make the devices more accessible and affordable for millions of Americans. (Treisman, 8/16)
Over-The-Counter Hearing Aids Expected This Fall In US
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from a hearing aid, though only about one-fifth of people with hearing problems currently use one. “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, told reporters Tuesday. (Perrone, 8/16)
On the potential price impact of the changes —
How Much Less Will Hearing Aids Cost With Over-The-Counter Option?
In a report from 2016, the National Academies of Sciences, Engineering and Medicine said that "the average retail price for a pair of hearing aids in 2013 was $4,700, which reflected the cost of both the hearing aids and professional services." The announcement by the FDA on Tuesday comes after Congress passed the Over-the-Counter Hearing Aid Act in 2017, which called on the agency to allow for the over-the-counter sale of hearing aids. Biden issued a similar executive order in 2021. (Impelli, 8/16)
FDA Allows Retail Sales Of Hearing Aids To Lower Cost, Broaden Access
The agency estimates the new class of devices would save consumers about $2,800 for a pair of hearing aids, officials said. Some hearing aids cost more than $5,000 between the price of the device and a professional fitting. Medicare covers a diagnostic test but does not pay for the device. ... The agency made changes from a proposed rule last October based on public comments from consumers, stakeholders and experts. The final rule requires retail hearing aids to lower maximum sound and to include a user-adjustable volume control. The final rule also limits how deep the devices can be placed in the ear canal. (Alltucker, 8/16)