Think how awful—and dangerous—it would be if the vast majority of people who needed eyeglasses didn’t have them. That’s the situation today with hearing aids.
According to one study, about 50 million Americans have significant hearing loss, most in both ears, including nearly 30 percent of those in their fifties, 45 percent of those in their sixties, 68 percent of those in their seventies, and 90 percent of those over 80. Yet only about one in seven hearing-impaired people uses a hearing aid.
As we previously reported, hearing loss can not only impair quality of life and lead to social isolation, but it has also been linked to a wide range of adverse health effects, including depression, cognitive decline, and even fall-related fractures. The main barrier to hearing aid use in the U.S. is the high cost—averaging about $2,400 per ear (not counting replacement batteries) for a device that has to be replaced every five years or so—which Medicare doesn’t cover.
Why the high prices? By law, the devices have to be sold through licensed audiologists (who typically bundle them with a package of services). What’s more, competition between makers is limited, and comparison shopping is difficult.
The Veterans Administration does provide for hearing aids for vets (paying greatly discounted bulk prices, of course), as do countries such as the UK, Denmark, and Switzerland, as part of basic health coverage—a perk of “socialized medicine.” Fortunately, a rare bipartisan bill recently passed by Congress (sponsored by Senators Elizabeth Warren and Chuck Grassley) will enable the FDA to expand access and “take important steps to fix a broken market for hearing aids.” The FDA can now work on regulatory changes that will create a new federal classification for over-the-counter (OTC) hearing devices, which will have to meet specifications for quality and safety.
Currently the FDA allows only the sale of OTC personal sound amplification products (PSAPs), but it doesn’t regulate them because they aren’t considered medical devices. Relatively inexpensive, PSAPs are not hearing aids per se—they only provide amplification and can’t claim to treat hearing loss. They can help some people with mild to moderate hearing loss, but since they are unregulated, they varygreatly in quality.
This was seen in a study in the Journal of the American Medical Association in July 2017, which compared five PSAPs with a conventional hearing aid in 42 older people with mild to moderate hearing loss. Four PSAPs (costing $270 to $350 each) were selected because they performed well in acoustic testing by the researchers; the fifth ($30) was chosen because it is widely sold in stores and online.
Three PSAPs (Sound World Solutions CS50+, Etymotic BEAN, and a now-discontinued brand) improved understanding of speech nearly as well as the pricey hearing aid did, and one (Tweak Focus) helped a little, while the $30 one (MSA 30X Sound Amplifier) actually worsened speech understanding. Clearly, quality control and regulation are necessary.
Technology companies have created many acoustic and electronic innovations in recent years. If they can make smartphones and wireless speakers, think what they’ll do for hearing aids, especially once the competition heats up. The result will be OTC hearing aids that are far better than any PSAP now on the market. Consumers will still be able to consult an audiologist for personalized services, if they wish. Allowing companies to create and market a new generation of OTC hearing aids meeting FDA standards should reduce costs, encourage innovation, and allow millions of Americans to hear much better.
Also see Hearing Loss: Don't Suffer in Silence.