Deregulation of Hearing Aids Will Lower Cost and Increase Innovation

(p. B5) Hearing aids typically cost thousands of dollars, require multiple visits to specialists and often aren’t covered by health insurance. Untreated hearing loss is associated with cognitive decline, dementia and other harms. Overcoming barriers to hearing treatment may significantly improve Americans’ health.

The federal government is poised to help. Congress in 2017 passed legislation that would let anyone buy hearing aids approved by the Food and Drug Administration without a prescription from an audiologist. The F.D.A. has missed a deadline to release draft guidelines for this new category of over-the-counter hearing aids.

Experts told me that when the F.D.A. moves ahead, it’s likely to lead to new products and ideas to change hearing aids as we know them.

. . .

It is already possible to buy a hearing helper — they can’t legally be called hearing aids — without a prescription. These devices, called personal sound amplification products or PSAPs, vary wildly in quality from excellent to junk.

. . .

Nicholas Reed, director of audiology at the Johns Hopkins Cochlear Center for Hearing and Public Health, told me that the F.D.A. process should provide a path for the best PSAPs to be approved as official over-the-counter hearing aids. He expects new companies to hit the market, too.

You may doubt that a gadget you buy next to the toilet paper at CVS could be a serious medical device. Dr. Reed’s research, however, has found that some hearing helpers for $350 or less were almost as good as prescription hearing aids for people with mild-to-moderate hearing loss.

Dr. Reed described the best lower-cost devices as the Hyundai of hearing help. (This was a compliment.) They aren’t flashy, but they will get many people safely and effectively where they need to go. He also imagines that the F.D.A. rules will create the conditions for many more people to buy hearing aids — both over the counter and by prescription.

. . .

Health care in the United States can often feel as if it’s stuck, and technology is usually not the solution. But with hearing aids, technology and a change in government policy could bring helpful health innovation.

For the full commentary, see:

Shira Ovide. “ON TECH; Affordable and Accessible Hearing Aids.” The New York Times (Monday, April 19, 2021): B5.

(Note: ellipses added.)

(Note: the online version of the commentary has the date April 12, 2021, and has the title “ON TECH; Hearing Aids for the Masses.”)

Reed’s research mentioned above is documented in:

Reed, Nicholas S., Joshua Betz, Nicole Kendig, Margaret Korczak, and Frank R. Lin. “Personal Sound Amplification Products Vs a Conventional Hearing Aid for Speech Understanding in Noise.” JAMA 318, no. 1 (July 4, 2017): 89-90.

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