FDA Releases Agenda for April 21 Workshop on Regulations

19 Apr , 2016

The FDA has released the agenda for its April 21, 2016 workshop on “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.” The Workshop can be viewed viaFDA webcast.

As previously announced by theHearing Industries Association (HIA), Dave Fabry, PhD, vice president of audiology and professional relations for Starkey Hearing Technologies, will represent HIA on a panel that will examine “Quality Standards for Manufacturing Hearing Aids.” 

Representatives of the Acoustical Society of America, Consumer Technology Association, and Dolby Laboratories will also participate on the quality panel. Panelists will examine topics ranging from the importance of the FDA’s Quality System Regulation (QSR) to whether third-party voluntary standards could replace mandatory FDA controls for a new “basic” class of hearing aid as recommended in an October 2015 report by the President’s Council of Advisors on Science and Technology (PCAST).

Robert Califf, MD, FDA Commissioner, will open the workshop which will also feature a review of the PCAST report as well as an update on the Institute of Medicine’s Study on Accessible and Affordable Hearing Health Care for Adults and an overview of FDA’s hearing aid regulations. The workshop also includes a Public Speakers Forum, and 27 individuals are scheduled to speak.

Background on Topics Covered in the FDA Workshop

PCAST claimed in its October 2015 report that FDA regulations, specifically the QSR, have a negative impact on the pace and level of innovation in the hearing aid industry and should be scrapped for the new “basic” hearing aid class to speed innovation.  This conclusion was based on PCAST’s inaccurate assertion that the hearing aid industry features “low innovation,” a claim which was debunked by HIA in our PCAST Response.  HIA notes that QSR standards have no negative impact on either the level or pace of innovation given that each hearing aid manufacturer introduces a wide variety of new hearing aid models annually, many of them on the cutting-edge of technological innovation. The QSRs were adopted in order to help ensure that consumers receive safe and effective medical devices. Exempting “basic” hearing aids from this requirement will neither foster innovation nor protect consumers.

As noted previously by the HIA, the FDA has also reopened its comment period regarding the Agency’s 2013 draft PSAP Guidance document, and HIA will formally urge the Agency to finalize and enforce this Guidance to further clarify the distinction between regulated hearing aids, and unregulated PSAPs.

Source: HIA; FDA

Image credit: FDA