There should be a category of apps and wearables that allows for the tools to be both regulated but also offered “over the counter,” Nicolas Terry, professor of law at Indiana University, argues in a post to the Health Affairs Blog.
Terry says the advancements being made in the hearing aid field are one example of how such a category could work. He points to a report published last year by the President’s Council of Advisors on Science and Technology (PCAST) that made recommendations on such devices.
The report’s authors said that physicians or audiologists should offer a portable copy of any prescription to patients and that the U.S. Food and Drug Administration should carve out a class of basic hearing aids that can be classified as medical devices while also being available over the counter (OTC).
PCAST also released a report in March with recommendations for the federal government when it comes to advancing policies to help older Americans live more independent lives.
While the FDA does say that personal sound amplification products are not medical devices, “it is almost farcical to pretend that PSAPs are being used only by bird-watchers,” Terry says.
He adds that there are very few devices available OTC.
“In a sense, therefore, the FDA preserves professional hegemony: if devices tend to do what doctors do ... or are sufficiently high risk that they should only be used by professionals, then FDA regulation will consign them to distribution through professional channels,” he writes.
A category of regulated devices available OTC, he reiterates, would allow for light regulation by the FDA while also allowing experimentation with new categories for devices that may not fall under the traditional framework. In addition, it may open up more avenues of innovation in hearing health and other areas, Terry says.
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