otc hearing aids executive order

New Executive Order on Over-the-Counter Hearing Aids Released by White House

WASHINGTON, D.C. — On July 9, U.S. President Biden signed a sweeping executive order that is said to be aimed at helping “promote greater competition in the American economy”. One particular section of the order addresses the long-anticipated rules on the classification of over-the-counter (OTC) hearing aids.  The President’s order directs the U.S. Department of…

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otc hearing aids fda

FDA Adds Proposed OTC Hearing Aid Rule to Agenda for Possible June Release

The Food and Drug Administration (FDA) Spring 2021 regulatory agenda indicates that agency could, as soon as this month, release its proposed rule to establish an over-the-counter (OTC) category of hearing aids in the United States. The regulatory agenda, released last week, says the FDA expects to publish the proposed rule, “Medical Devices; Ear, Nose…

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otc hearing aids fda approval

Mass Eye and Ear Experts Urge FDA to Allow OTC Hearing Aids

BOSTON, MASSACHUSSETTS — Hearing loss experts at Mass Eye and Ear are advocating for the U.S. Food and Drug Administration (FDA) to implement a law passed by Congress permitting the sale of over-the-counter (OTC) hearing aids. In a new column published November 19, 2020 in The New England Journal of Medicine, the experts write that the FDA has remained silent…

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otc hearing aids fda

Senators Urge FDA to Initiate ‘Overdue Rules’ for OTC Hearing Aids

WASHINGTON, D.C. – United States Senator Elizabeth Warren (D-Mass.), a member of the Senate Health, Education, Labor and Pensions Committee, and Senator Chuck Grassley (R-Iowa), Chairman of the Senate Finance Committee, urged the Food and Drug Administration (FDA) to initiate its overdue rules for over-the-counter (OTC) hearing aids “without further delay”. (read full letter here)…

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psap hearing aid mild hearing loss

JAMA Study: Premium and Basic Hearing Aids Do Not Outperform PSAPs for Mild or Moderate Losses

Since 2015, with the release of the PCAST report, over-the-counter (OTC) hearing aids have been a hot topic among professionals who work directly with persons with hearing loss. Although OTC hearing aids have not been fully codified by the FDA and does not officially yet exist as a product category, it is believed by many…

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psap otc hearing loss benefits

New Studies Show Limitations, Potential Benefits of PSAPs

Two recently published studies from independent hearing aid research labs indicate that some personal sound amplification devices or PSAPs could offer benefit to individuals with milder hearing loss. The first study, published on-line in September in the American Journal of Audiology, was conducted by researchers at the University of Iowa. In the laboratory-based study, they…

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age related hearing loss

News Roundup for October 25: Trends in Consumer-driven Healthcare that Could Change Audiology

Even though the FDA’s OTC legislation seems to generate many of the industry headlines these days, there are still a lot of notable news items that could have a direct impact on how audiology is practiced over the next generation, so before you settle on your Halloween costume for this year’s big bash, spend a…

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cbs otc hearing aid story

CBS Sunday Morning Turns Up the Volume on Hearing Aids

The evolving hearing aid industry was the subject of a nearly 10-minute in-depth feature on CBS Sunday Morning.  David Pogue, tech critic for Yahoo Finance, talked to several respected industry figures, including Starkey executives Bill Austin and Achin Bhowmik, about recent technological breakthroughs in hearing aids. A substantial portion of the television news magazine piece…

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audiologist survey 2018

The 2018 Hearing Professional Dispensing Survey

TUCSON, ARIZONA — Hearing Health & Technology Matters (HHTM), a leading online resource for hearing professionals and consumers with hearing loss, has released the results of their 2018 Hearing Professional Dispensing Survey. The online survey was conducted in May 2018, with the purpose of exploring professional opinion and dispensing patterns in the United States. Approximately 300 audiologists…

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otc hearing aids statement opinion

Some Experts Say the OTC Consensus Statement a Rubber Stamp for the Status Quo

Independent scientific research and unbiased, transparent opinion plays a critical role in any credible profession. It is the application of the scientific method in the problem-solving process and the endless striving to understand the truth, that separates, say, the practice of modern medicine from alchemy. At the same time, it is easy to find recent…

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