Tag: PCAST

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FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.

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A Counterpoint to the PCAST Recommendations

David Smriga points out that OTC/DTC hearing aids have their place, but for the majority of adults with mild-to-moderate age-related hearing losses, a guided process including fitting verification and auditory rehabilitation is needed to achieve maximum benefit with amplification. Consumers should be directed toward professional care practices that offer these services, not away from them. Read the point-by-point argument against the PCAST’s recent conclusions.

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Stakeholders Weigh in on PCAST Letter

On October 26, the President’s Council of Advisors on Science and Technology (PCAST) released its official report to the President about hearing technologies and mild-to-moderate hearing loss in older adults. Since then, several key stakeholders have weighed in on the implications of the PCAST report with responses ranging from outright opposition to full support. Brian Taylor’s blog summarizes initial comments from stakeholders in the hearing healthcare field.

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ADA Lends Qualified Support for PCAST Recommendations

In giving qualified support to the PCAST recommendations, ADA is the first among the hearing care professional organizations to publicly endorse, at least in principle, the PCAST’s report to the president. However, ADA listed a number of important qualifications emphasizing the importance of the audiologists’ role in hearing evaluation and diagnostics, dispensing, and aural rehabilitation, as well as some necessary standards for PSAPs, entry-level devices, and hearables.

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HLAA Supports Recommendations of PCAST Report on Hearing Loss

The Hearing Loss Association of America (HLAA), a national organization representing people with hearing loss, has announced that it enthusiastically endorses a new report issued by the President’s Council of Advisors on Science and Technology (PCAST). This announcement comes on the heels of an announcement from HIA, which strongly opposes the PCAST recommendations.

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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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PCAST Public Meeting to Discuss Hearing Technologies, Aging

The President’s Council of Advisors on Science and Technology (PCAST), an advisory group of scientists and engineers who directly advise the President, will be holding a public meeting on September 18, 2015 to discuss “PCAST Technology to Help People as They Age: Hearing Technologies” at 10:00 AM to 12:00 PM (ET). Online registration is available.

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