Published by Frank Fitzpatrick
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The move toward the deregulation of hearing devices that could help 48 million Americans suffering from mild-to-moderate hearing loss is now in its third presidency. In 2015 President Barack Obama’s Council of Advisors on Science and Technology issued a report with the intention to drastically reduce the cost of hearing aids, drive innovation in technology, and increase competition and affordable consumer options for health and wellness. The council’s recommendations were echoed by a 2016 report from the National Academies of Science, Engineering and Medicine. In August 2017, President Trump signed the Over-the-Counter (OTC) Hearing Aid Act into law, giving the FDA a statutory deadline of three years to publish their guidelines.
That publication was originally scheduled by the agency for November 2019. Advocates of the bill, as well as companies positioning to capitalize on the new markets it would help create, eagerly awaited the announcement of the official guidelines. The November date, and even the August statutory deadline that followed, came and went. The FDA never delivered. According to phone conversations between our office and FDA representatives, as recent as May of this year, the agency still didn’t have a new release date on the calendar....
Read the full article on Forbes here.
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