Massachusetts otolaryngologists call on FDA to approve OTC hearing aids


Hearing loss specialists at Boston-based Massachusetts Eye and Ear published a column in The New England Journal of Medicine calling on the FDA to approve over-the-counter hearing aid devices, according to a Nov. 18 press release.

Kevin Franck, PhD, and Vinay Rathi, MD, wrote that the FDA has remained silent after missing a deadline to implement the Over-the-Counter Hearing Aid Act of 2017, the release said. They say hearing aids aren't usually covered by insurance, and new regulations could increase access to the devices.

The doctors recommended the FDA require clinical studies of novel OTC hearing aids or new models that are substantially different from previously approved devices, the release said. They also called for studies looking at the effectiveness of OTC hearing aids and user-fitted aids.

Read the full press release here and access the column here.

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