Health

Hearing aids may soon be sold over-the-counter

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

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

They would be sold over the counter to customers who could test their own hearing with cellphone apps or online programs and adjust sound parameters themselves.

The devices “will be widely used by older people,” just as ear buds 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, the agency said it planned to take “steps necessary to propose to modify our regulations to create a category of [over-the-counter] hearing aids.”

Early in January, the Federal Trade Commission announced plans for a meeting on hearing health care in April. That agency played an important role in ensuring consumers get copies of eyeglass prescriptions that allow them to shop around for good deals. For the most part, that doesn’t happen with hearing aids today.

Whether agency priorities will change under the new Trump administration isn’t certain. But technology is developing rapidly.

Older adults with mild to moderate hearing loss are expected to be a prime market for new products marrying hearing aids with consumer electronics.

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

Yet only 20 percent of those with an impairment use hearing aids – because of their high cost (an average $4,700 a pair), a lack of insurance coverage (traditional Medicare, for example, doesn’t pay for them), stigma, denial and difficulties getting the appropriate care.

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 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 a growing body of research linking hearing loss to cognitive decline, depression, the onset of dementia, falls, poor physical functioning and social isolation. The longer people delay seeking help, research suggests, the more at risk they become.

Several recent developments are of note as consumer electronics companies, hearing-aid manufacturers, audiologists, physicians, consumer advocates and regulators prepare for a surge of new devices and changes in the health-care system that deals with hearing:

- 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. In December, the agency eliminated that requirement.

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. Rather than see a physician, people buying hearing aids 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 evaluations.

- Proposed legislation

Sens. Charles E. Grassley, R-Iowa, and Elizabeth Warren, D-Mass., said recently that they would soon introduce legislation endorsing the sale of hearing aids without such 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 statement.

Six companies control nearly 98 percent of the hearing aid market in the United States. Nearly two-thirds of people with severe hearing loss report being unable to afford the devices, whose cost is generally bundled with professional fees for evaluation, fitting and follow-up care.

Organizations representing hearing professionals are deeply divided.

The American Speech-Language-Hearing Association, an organization representing audiologists and speech-language pathologists, said it doesn’t believe consumers can adequately self-diagnose hearing problems and opposes over-the-counter devices.

Ian Windmill, president of the American Academy of Audiology, said his group is taking a “wait-and-see stance” until the FDA acts. But he added that his group, which represents more than 12,000 audiologists, believes that professionals should evaluate hearing loss.

Another group, the Academy of Doctors of Audiology, said it believes the benefits of expanding access to hearing devices outweigh the risks; it supports over-the-counter products.

The senators plan to introduce their legislation, which asks the FDA to issue regulations ensuring the safety and effectiveness of these devices, in this new congressional session.

“Administrations shift and legal challenges occur,” Grassley said in a statement, adding that getting the law on the books would ensure needed “certainty going forward.”

- Creating standards

One area of considerable confusion is the difference between hearing aids and personal sound amplification products, or PSAPs.

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

In 2009, the FDA drew a distinction between PSAPs and hearing aids based on what the agency called their “intended use.” PSAPs were considered unregulated consumer electronics products for people with normal hearing who wanted to hear more sharply - for instance, during birdwatching. 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.

Stephanie Czuhajewski, executive director of the Academy of Doctors of Audiology, said she believes higher-end PSAPs will become over-the-counter hearing aids.

In the meantime, the Consumer Technology Association has prepared standards for PSAPs meant to make it easier for people to understand what they’re buying. The standards, which address issues such as maximum output, peak output and sound distortion may be published as early as next month.

“The intent is to provide a ‘Good Housekeeping Seal of Approval’ for PSAPs,” said Mead Killion, an audiologist who founded Etymotic Research, an Illinois company that manufactures hearing devices. Currently, there is no easy, standardized way to compare these devices.

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This column is produced by Kaiser Health News, an editorially independent news service and a program of the Kaiser Family Foundation.

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