FDA category needed to drive wearable hearing devices forward

Medical devices

A new report from the National Academies of Sciences, Engineering, and Medicine describes access to hearing health services and solutions as inadequate and calls on the U.S. Food and Drug Administration to create a new regulated device category for wearable hearing tools available over the counter.

Such alternative models of hearing-loss solutions are necessary, states a viewpoint published in the Journal of the American Medical Association. The authors--from Johns Hopkins, Wake Forest and Duke universities--note that the report is timely, as more attention is being focused on hearing loss as a public health issue.

"In parallel, the Academies committee recommended that implementing innovative approaches of hearing healthcare services delivery [eg, through community health workers, telehealth] are needed to increase access and to complement the established clinic-based medical model," the authors say.

As FierceMobileHealthcare previously reported, eight out of 10 smartphone users anticipate using advanced sensory technologies to gain health insight in relation to memory, hearing and vision, according to a consumer trends report from Ericsson ConsumerLab.

Regulations stopping consumers from obtaining over-the-counter hearing aids are not necessary or in the best interest of consumers, states the Academies' report, which was funded by the Centers for Disease Control and Prevention, the Department of Defense, the Department of Veterans Affairs, the U.S. Food and Drug Administration, the Hearing Loss Association of America, the National Institute on Aging and the National Institute on Deafness and Other Communication Disorders.

The viewpoint notes a need for developing common standards to allow seamless and wireless interoperability of hearing aids with other technologies involving sound transmission, such as smartphones.

This would "substantively improve the quality of the incoming sound signal and in turn the acceptability and utility of using a hearing technology to the consumer," state the viewpoint's authors. "Importantly, actions by the FDA as recommended by the committee to create a new device category for over-the-counter wearable hearing technologies could significantly increase societal use of hearing technologies and help spur efforts to better integrate these devices with other forms of consumer and sound transmission technologies," they say.

For more information:
- read the JAMA viewpoint
- check out the National Academies report

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