Quality and Innovation to be Discussed at Upcoming FDA Hearing Aid Meeting

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…

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Upstart Belgium Company, Jacoti, Looks to Bring Hearing Care to Masses

During the recently concluded Consumer Electronics Show (CES) in Las Vegas, Jacoti, bvba of Belgium, was named a CES 2016 Innovation Awards honoree. The company won for its Jacoti Hearing Suite. Judging from its press releases and website, Jacoti has a clear mission of bringing hearing self-testing and amplification apps directly to consumers and is…

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home hearing test

FDA Gives Approval for Over-The-Counter Home Hearing Test

SAN LEANDRO, CALIFORNIA — Over the past year, there has been growing interest in the morphing of consumer electronics and medical devices. New product categories are being created and the hearing care industry seems to be on the brink of some significant changes, especially in light of the recent non-binding PCAST recommendations to re-regulate the…

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fda hearing aid meeting

FDA Will Convene April Hearing Aid Meeting

SILVER SPRINGS, MARYLAND — In a January 6th press release the US Food and Drug Administration (FDA) announced it will host a public workshop, “Streamlining Good Manufacturing Practices (GMPs) for Hearing Aids,” on April 21, 2016, at the FDA’s headquarters in Silver Spring, Maryland. The workshop will outline the agency’s perspective on the current GMPs…

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cassel pcast

Why Did Dr. Cassel Change Her Mind About Consumer-Driven Healthcare?

By now everyone in the hearing healthcare industry is familiar with the facts, but they bear some repeating:  There are millions of Americans with mild to moderate age-related hearing loss, and a mere 15 to 30% of this group use hearing aids, which are expensive, rife with stigma, and rarely covered by insurance. The consequences of…

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ada pcast support hearing aid

ADA Supports PCAST; Offers Additional Guidance

LEXINGTON, KENTUCKY — Following their annual meeting in Washington DC, the Academy of Doctors of Audiology (ADA) issued a position statement on the recent PCAST report.{{1}}[[1]]Aging America & Hearing Loss: Imperative of Improved Hearing Technologies.[[1]] In a press release, authored by recently elected ADA president Rita Chaiken, ADA supports the PCAST report because the recommendations “present…

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hearing screening smartphone

Wheels in Motion at IEEE for Creating Standards for Smartphone Hearing Pre-screeners 

In a story first reported by Dr. Abram Bailey at Hearing Tracker, the Institute of Electrical and Electronics Engineers (IEEE) has “invited all interested parties to notify if they wish to actively participate in the development of IEEE P2650™ Standard For Enabling Mobile Device Platforms To Be Used As Pre-Screening Audiometric Systems.” The IEEE is a large,…

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PCAST Issues Eye-Opening Report, HIA Strongly Opposes

On Friday, October 23rd the President’s Council of Advisors on Science and Technology (PCAST) released a report entitled, Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. After several public meeting held over the past year, which were reported  previously by HHTM, PCAST members voted and approved the report. It will be published in the…

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