FDA releases new hearing aid guidance, in effect immediately

The FDA has issued a release that details ways to improve access to hearing aids for the 30 million Americans currently suffering from hearing loss. The guidance document will take effect immediately.

With hearing loss effecting a large portion of Americans, and steadily growing as the baby boomer generation reaches the golden years,

Accessibility to hearing aids can be difficult—only 20 percent of those who need a hearing aid have one. The FDA's guidance document states that organization will no longer enforce the requirement that anyone over 18 receive a medical evaluation or sign a waiver before purchasing a hearing aid. Instead, the FDA hopes to foster the development of new over-the-counter hearing aids at lower prices.

“Today’s actions are an example of the FDA considering flexible approaches to regulation that encourage innovation in areas of rapid scientific progress,” said FDA Commissioner Robert Califf, MD. “The guidance will support consumer access to most hearing aids while the FDA takes the steps necessary to propose to modify our regulations to create a category of over-the-counter hearing aids that could help many Americans improve their quality of life through better hearing.”

The President's Council of Advisors on Science and Technology (PCAST)—in its 2015 recommendations to improve hearing aid innovation, affordability and access—stated that the biggest barriers to fulfilling these milestones were government regulations. In response, the FDA issued this new guidance.

In the future, the FDA will further address PCAST recommendation in regards to the framework of over-the-counter hearing aids without the need for a consultation with a credential dispenser.