Reporting by Nick Paul Taylor
Photo by Sarah Silbiger via Getty Images
The Food and Drug Administration’s final guidance on the regulatory requirements for hearing-aid devices and personal sound amplification products has taken a step toward publication. The guidance would create a new category of over-the-counter hearing aids, after Congress passed a law in 2017 requiring the FDA to allow for retail sales of the devices for adults with mild- to moderate-hearing loss.
On Friday, the Office of Information and Regulatory Affairs completed its review of the guidance. The OIRA found the document to be consistent with the principles set out in an executive order on regulatory planning, while changes have been made since the FDA sent it for review.
At this stage, the nature and extent of the changes are not known publicly. The FDA...
Read the original article on MedTech Dive here.
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