FDA approves hearing aids to be sold over the counter!
This is a Big F*cking Deal for millions of people.
Last July, President Biden issued an executive order which, among other things, included this provision:
Hearing Aids: Hearing aids are so expensive that only 14% of the approximately 48 million Americans with hearing loss use them. On average, they cost more than $5,000 per pair, and those costs are often not covered by health insurance. A major driver of the expense is that consumers must get them from a doctor or a specialist, even though experts agree that medical evaluation is not necessary. Rather, this requirement serves only as red tape and a barrier to more companies selling hearing aids. The four largest hearing aid manufacturers now control 84% of the market.
In 2017, Congress passed a bipartisan proposal to allow hearing aids to be sold over the counter. However, the Trump Administration Food and Drug Administration failed to issue the necessary rules that would actually allow hearing aids to be sold over the counter, leaving millions of Americans without low-cost options.
In the Order, the President directs HHS to consider issuing proposed rules within 120 days for allowing hearing aids to be sold over the counter.
A year later, and voila (via the New York Times):
The Food and Drug Administration decided on Tuesday to allow hearing aids to be sold over the counter and without a prescription to adults, a long-sought wish of consumers frustrated by expensive exams and devices.
The high cost of hearing aids, which are not covered by basic Medicare, has discouraged millions of Americans who have hearing loss from buying the devices. Health experts say that untreated hearing loss can contribute to cognitive decline and depression in older people.
Under the new rule, people with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores as soon as October, without being required to see a doctor for an exam to get a prescription.
The F.D.A. cited studies estimating that about 30 million Americans experience hearing loss, but only about one-fifth of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less costly, and perhaps, more innovative designs. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to roughly $4,700 elsewhere.
...Federal officials estimated $2,800 in savings on the cost of a pair of hearing aids. Brian Deese, White House director of the National Economic Council, said making the change was a “top priority” for the president.
For millions of Americans, hearing aids and the doctor’s visit to get them prescribed are too expensive. In the executive order I issued last year to increase competition in key industries and lower costs, I called on the FDA to finally make hearing aids available over the counter.
Today, the FDA is doing just that. 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. This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing. And, it’s the latest action we are taking to make our economy more competitive and less concentrated. When too few companies dominate, American consumers pay higher costs. We’re finally building an economy that works for working families.