FDA Clears Path For Hearing Aids To Be Sold Over the Counter

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 $1,400at Costco to roughly $4,700elsewhere. The F.D.A.’s final rule takes effect in 60 days. Industry representatives say device makers are largely ready to launch new products, though some may need time to update labeling and packaging or to comply with technical details in the rule. “This could fundamentally change technology,” said Nicholas Reed, an audiologist at the Department of Epidemiology at Johns Hopkins Bloomberg School of Public Health. “We don’t know what these companies might come up with. We may literally see new ways hearing aids work, how they look.”