fda otc hearing aid rule

Grassley, Warren Introduce Bill to Increase Pressure on FDA to Issue Final OTC Hearing Aid Rule

WASHINGTON, D.C. — Today, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) introduced new legislation that would require the Food and Drug Administration (FDA) to issue a final rule regarding over-the-counter hearing aids.   Their bipartisan Delivering Over-the-Counter Hearing Aids Now Act follows the FDA’s proposed rule implementing over-the-counter hearing aids in October 2021, which was…

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fda otc hearing aid rule

Senators Grassley and Warren Urge FDA to Take Immediate Action on OTC Hearing Aid Rule

WASHINGTON, D.C. – In a letter to U.S. Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) expressed their support for key provisions in the FDA’s proposed rule for regulating over-the-counter (OTC) hearing aids.   The FDA’s proposed rule is a direct result of the Over-the-Counter Hearing Aid Act,…

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starkey hearing

Starkey’s Brandon Sawalich Issues Statement Regarding President Biden’s Competition Executive Council Announcement

Starkey President and CEO, Brandon Sawalich has issued a statement following comments from President Biden regarding the Competition Executive Council.  In releasing the statement, shown below, Starkey reiterated that the company “supports increasing hearing aid accessibility, but not at the cost of patient safety”. “Hearing aids are a medical device. They are built with the…

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otc hearing aids auditory insight

Auditory Insight Assesses Impact of FDA Proposal for OTC Hearing Aids

NEW HAVEN, CONNECTICUT — Auditory Insight, a leading consultancy for the hearing healthcare industry, analyzes the impact of the FDA’s recently proposed rule for over-the-counter (OTC) hearing aids in a special research bulletin.   Download the research commentary: New FDA Proposal for OTC Hearing Aids The Over-the-Counter Hearing Aid act, passed in 2017, directs the FDA to create…

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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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fda otc hearing aid rule

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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