PCAST Recommends Creation of “Basic” OTC Hearing Aid Category; Easing of PSAP Regulations

The President’s Council of Advisors on Science and Technology (PCAST) held an open teleconference on October 23, 2015 to discuss its report, "Aging America & Hearing Loss: Imperative of Improved Hearing Technologies." Among the PCAST's recommendations are a distinct FDA category for “basic” OTC hearing aids without the requirement for consultation with a credentialed dispenser, and the FDA's withdrawal of its draft guidance document regarding personal sound amplification devices (PSAPs), referring instead to this new category as “devices for discretionary consumer use.” The Hearing Industries Assn (HIA) strongly disagrees with the PCAST and says it will be responding to the numerous errors in the report.