Dave Fabry, PhD
According to HIA, Dr Fabry will be participating on a panel that will focus on “Quality Standards for Manufacturing Hearing Aids.” The panel will examine topics ranging from the importance of 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 from the President’s Council of Advisors on Science and Technology (PCAST).
PCAST claimed in its 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 its formal response to PCAST. 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. The HIA asserts that exempting “basic” hearing aids from this requirement will neither foster innovation nor protect consumers.
As noted previously, 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, Andy Bopp
