Search Results for: otc

NASEM Committee Recommends New OTC Hearing Aid Class, End to Waiver System, and Unbundling of Hearing Aid Prices

Among a dozen recommendations, the Committee on Accessible and Affordable Hearing Health Care for Adults would like to see the FDA establish an over-the-counter class of hearing devices, an end to the “waiver system,” hearing aids that have open programming, and portability of consumers’ audiograms and hearing aid programming information.

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FDA Approves First OTC Hearing Test

iHear Medical announced that it received FDA clearance for the iHearTest, the first hearing test approved for over-the-counter (OTC) sales. The iHearTest is intended to profile hearing ability based on WHO guidelines, targeting adults who suspect they have hearing loss, or those reluctant to seek professional evaluation for a basic hearing assessment.

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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hearing aids without the requirement for consultation with a credentialed dispenser, and the FDA’s withdrawal of its draft guidance document regarding personal sound amplification devices (PSAPs), referring instead to this new category as “devices for discretionary consumer use.”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.

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Turning It Down a Notch

The Baby Boomer generation thought they would hear the music forever, however, many are now having trouble hearing it at all. This problem isn’t just one for older Americans. According to studies conducted in 1999 by the US Food and Drug Adm

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