otc hearing aids fda

FDA Proposes Rule to Create New OTC Hearing Aid Category 

Today, the U.S. Food and Drug Administration issued a landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans. The agency proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold…

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Senators Call on FDA to Issue Over-the-Counter Hearing Aid Regulations by November 6th

WASHINGTON D.C. – United States Senators Elizabeth Warren (D-Mass.) and Chuck Grassley (R-Iowa) urged the Food and Drug Administration (FDA) to issue new regulations for over-the-counter (OTC) hearing aids without delay, in accordance with President Biden’s Executive Order on Promoting Competition in the American Economy and their bill, the Over-the-Counter Hearing Aid Act, which was signed into law over…

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Starkey’s Brandon Sawalich Pens Opinion Piece on Misinformation Surrounding Hearing Aids

Earlier this week, an opinion piece written by Starkey President and CEO, Brandon Sawalich, was published in the Morning Consult, a popular Washington D.C.-based news site. The piece, entitled “Misinformation around hearing aids could cause harm”, points out that stigma is the biggest barrier to hearing aid adoption, not cost.  “Moreover, the notion that cost…

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california otc hearing aid warning

California Attorney General Issues Consumer Alert on Hearing Aids Sold Online or Over-the-Counter

OAKLAND, CALIFORNIA – California Attorney General Rob Bonta issued a consumer alert today, warning Californians to exercise caution when purchasing direct-to-consumer hearing products, such as hearing aids, over-the-counter or online. According to a news release, “…the growing popularity, availability, and confusion about these products, the Attorney General urges the public to educate themselves about their…

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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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