Cheaper hearing aids on horizon

Kaiser Health News
Saturday, January 21, 2017

Imagine seniors walking around with stylish ear devices that amplify and clarify sound and connect wirelessly to smart phones, tablets, televisions and digital assistants such as Amazon’s Alexa or Apple’s Siri.

That day is coming, sooner than you may think.

Technology is already moving in this direction, and consumer marketers such as Samsung, Bose Corp., and Panasonic Corp. are reportedly readying new products of this kind.

They’ll be sold over the counter, to customers who will test their own hearing with apps or online programs and adjust sound parameters.

The devices “will be widely used by older people,” just as earbuds are used by younger people today, predicted Richard Einhorn, a well-known composer who serves on the board of the Hearing Loss Association of America, a consumer group.

Recognizing market forces, the Food and Drug Administration is mobilizing. In December, Robert Califf, the FDA’s commissioner, said the agency planned to take “steps necessary to propose to modify our regulations to create a category of [over-the-counter] hearing aids.”

Older adults with mild to moderate hearing loss, including aging baby boomers, are expected to be a prime market for a new generation of products marrying hearing aid and consumer electronics hearable technologies.

More than 40 percent of people over the age of 60 have some degree of hearing loss, mostly mild to moderate; that rises to 80 percent of people older than 80.

Yet only 20 percent of those with some degree of impairment use hearing aids because of their high cost (an average $4,700 per pair), the lack of insurance coverage (traditional Medicare doesn’t pay for hearing aids), stigma, denial and difficulty navigating the hearing health system.

Hoping to expand access, the President’s Council of Advisors on Science and Technology came out in favor of low cost, over-the-counter hearing devices in October 2015. The National Academies of Sciences, Engineering, and Medicine seconded that recommendation in a major report on hearing health care published in June.

Both organizations cite research linked hearing loss to cognitive decline, depression, dementia, falls, poor physical functioning and isolation.

Removing barriers

For 40 years, the FDA has required that adults be examined by a doctor before purchasing a hearing aid or sign a waiver noting that they didn’t want to take this step. Last month, the agency eliminated that requirement for people over the age of 18.

The National Academies of Sciences’ expert panel on hearing health had noted that the rule “provides no clinically meaningful benefit” and could discourage people from seeking care. Instead of seeing a physician, adults signed the waiver 60 to 95 percent of the time.

Still, limits on access to hearing aids exist: All states restrict distribution of these devices to certified audiologists, physicians and device specialists. And some states still require medical tests.

Proposed legislation

Sens. Charles Grassley, a Republican from Iowa, and Elizabeth Warren, a Massachusetts Democrat, said last month that they would soon introduce new legislation endorsing over-the-counter hearing aids, sold without those restrictions.

The goal is to increase competition, lower costs and expand access to devices for people with mild to moderate hearing loss, Grassley said in a prepared statement.

Currently, six companies control nearly 98 percent of the hearing aid market in the U.S., contributing to high prices. Nearly two-thirds of people with severe hearing loss – many of them elderly – report being unable to afford the devices. The cost is generally “bundled” with professional fees for evaluation, fitting and follow-up care.

Creating standards

One area of considerable confusion is the distinction between hearing aids and personal sound amplification products, known as PSAPs.

This is a wide category of products, ranging from cheap devices that help amplify sound to sophisticated devices that resemble hearing aids in all but their name. In some cases, companies are marketing the exact same device as a hearing aid and a PSAP, sold at different prices.

In 2009, the FDA drew a distinction between PSAPs and hearing aids based on their “intended use.” PSAPs were considered unregulated consumer electronics products for people with normal hearing who wanted to hear more sharply – for instance, during bird watching. Hearing aids were regulated and considered medical devices meant for people with hearing impairment.

But technological advances have brought the two categories closer. And it’s well understood that people with hearing loss are using PSAPs as a cheaper alternative to hearing aids.