SILVER SPRING, MARYLAND — The Food and Drug Administration (FDA) will be conducting its greatly anticipated workshop on April 21 in Washington DC. The FDA 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 stemming from an October, 2015 report from the President’s Council of Advisors on Science and Technology (PCAST). Additionally, PCAST suggested in the October report that the QSR had a negative effect on hearing aid innovation, and recommended a direct-to-consumer, “basic” category of products for mild to moderate hearing loss.
HIA recently argued 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 every 12 to 18 months. HIA stresses that exempting “basic” hearing aids from this requirement will neither foster innovation nor protect consumers.
Dave Fabry, PhD, vice president of audiology and professional relations for Starkey Hearing Technologies, will represent the Hearing Instrument Association (HIA) as a panelist during the FDA’s April 21, 2016 Workshop on “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids.” According to a recent HIA press release, Dr Fabry will be on a panel focusing on “Quality Standards for Manufacturing Hearing Aids.”
HHTM Hearing News Watch will continue to monitor the FDAs April 21st workshop and provide updates as they occur.
PSAPs and Hearing Aids: What’s the Difference?
In other related news, a recent Audiology Online web-based course reviewed the electroacoustic and real ear aided response characteristics of a number of PSAPs on the market today. The general conclusion of the analysis, conducted by Northwestern University 4th year AuD student, Chase Smith, was that PSAP quality is uneven, with some performing similarly to traditional hearing aids and others far off the mark.
As previously noted by HHTM, the FDA will reopened its comment period regarding the Agency’s 2013 draft PSAP Guidance document, and HIA will formally urge the FDA to finalize and enforce this draft Guidance to further clarify the distinction between regulated hearing aids, and unregulated PSAPs.