Health & Medicine

Coming soon? Cheaper, over-the-counter hearing aids that link to your phone

For 40 years, until last month, federal law required every adult to be examined by a doctor before buying a hearing aid.
For 40 years, until last month, federal law required every adult to be examined by a doctor before buying a hearing aid. TNS

Imagine seniors 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.

That day is coming, sooner than you might think.

Technology is already moving in this direction, and consumer marketers including 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 cellphone apps or online programs and adjust sound parameters themselves.

The devices “will be widely used by older people,” just as earbuds are used by younger people today, said Richard Einhorn, a well-known composer who is 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, Dr. 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.”

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

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 older than 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 a 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 published in June.

Several recent developments are of note we prepare for a surge of new hearing devices and changes in the hearing health care system:

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

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 require medical evaluations.

Sens. Charles Grassley, R-Iowa, and Elizabeth Warren, D-Mass., 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.

Organizations representing hearing professionals are deeply divided.