These ‘hearables’ will be an affordable alternative to the current day, expensive and not so stylish hearing aids, the Chicago Tribune writes. They will also be sold over the counter and will provide access to hearing aids to many people that cannot afford them now because of the high costs (an average $4,700 per pair) and a lack of insurance coverage.
The devices "will be widely used by older people," like ear buds are used by younger people today, predicts Richard Einhorn, a well-known composer who serves on the board of the consumer Group Hearing Loss Association of America. Older adults with mild to moderate hearing loss are expected to be a prime market for new products marrying hearing aids with consumer electronics.
Recognizing market forces, the Food and Drug Administration is planning to take "steps necessary to propose to modify our regulations to create a category of [over-the-counter] hearing aids." And early in January, the Federal Trade Commission announced plans for a meeting on hearing health care in April. The FTC played an important role in ensuring that 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.
High costs form barrier
In the U.S., 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, 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.
It seems, more and more research shows, that lack of access to hearing aids is linked 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.
For example, regulatory barriers are bein removed, like the FDA requirement 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 this requirement.
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.
Also, 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.
One area of much 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." 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.