fda otc hearing aid regulations academy

American Academy of Audiology Board Meets with FDA, Congress, and Private-Payer Representatives

WASHINGTON, DC — Members of the board of the American Academy of Audiology (AAA) conducted meetings last week with the U.S. Food and Drug Administration (FDA), members of Congress, and representatives from the private-payer community. According to an announcement to its membership on October 30th, AAA said its board used the meetings to represent audiology’s…

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gn resound linx 3d hearing aid

After Launch of ReSound LiNX 3D, GN Posts Strong Q2 Results; CEO Says Company to Compete in Upcoming OTC Market

BALLERUP, DENMARK — GN Store Nord A/S announced the results of the company’s half-year financial report on August 17th, noting a 15% revenue growth in the second quarter (Q2), driven by strong performance at GN Hearing and GN Audio. According to the financial report, GN Hearing’s revenues increased by 12% in Q2, with an organic…

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Clementine Wear Wins National Science Foundation’s Hearable Challenge

On August 17, the National Science Foundation (NSF) and NineSigma announced that Samplified Audio and Clementine Wear were the winners of their Hearables Challenge. The Hearables Challenge was announced in April 2017 with the primary goal to showcase audio solutions that improve speech understanding in noise that can be applied to consumer audio products. The…

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trump signs otc hearing aid fda bill

It’s Official: President Trump Signs OTC Hearing Aid Legislation into Law

WASHINGTON, DC — On Friday, August 18, President Trump signed the FDA Reauthorization Act into Law. Within the FDA legislation, a provision was included that directs the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. After passing in the Senate earlier this month by a vote…

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audiologist otc hearing aid survey

How Do Audiologists Feel About OTC Hearing Aids? Survey Results Now Available

TUCSON, ARIZONA — Hearing Health and Technology Matters (HHTM), a leading online resource on all topics related to hearing, has released the results of their Audiologist OTC Hearing Aid Survey. The online survey was conducted between August 1st and August 8th, 2017, with the purpose of exploring the views of audiologists on the subject of Over-The-Counter (OTC)…

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william demant oticon otc

Oticon OTC Hearing Aids? William Demant Says it May Make OTC Devices if US Demand Develops

William Demant Holdings, one of the world’s largest hearing aid manufacturers, said it could start producing less expensive Over-The-Counter (OTC) hearing aids for the U.S. market if demand increases after the OTC legislation goes into effect. North America represents the largest and most lucrative market for Demant, the parent company to well-known hearing aid brand…

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warren otc bill passes senate

Legislators Applaud Passage of OTC Hearing Aid Bill

WASHINGTON, DC — Senators Elizabeth Warren (D-MA), Chuck Grassley (R-IA), Maggie Hassan (D-NH), Johnny Isakson (R-Ga.), Susan Collins (R-ME) and Claire McCaskill (D-MO), along with Representatives Joe Kennedy III (D-MA) and Marsha Blackburn (R-TN) applauded the passage of the Over-the-Counter (OTC) Hearing Aid Act as part of the Food and Drug Administration (FDA) Reauthorization Act…

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senate over counter hearing aid act 2017 passes

US Senate Passes OTC Hearing Aid Legislation

WASHINGTON, DC — The US Senate passed the FDA Reauthorization Act today. The legislation, as reported previously, contains a provision that directs the FDA to develop a category of over-the-counter (OTC) hearing aids for adults with mild to moderate hearing loss. A House version of the bill was passed last month. The OTC provision of…

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congress otc hearing aid legislation

UPDATE: OTC Hearing Aid Legislation: Where Are We Now?

Editor’s Note: On August 3, 2017, the US Senate passed the Over the Counter Act of 2017. The legislation, having already passed in the House, will now head to the president’s desk to be signed into law.   In November 2016, citing recommendations from the groundbreaking PCAST and NAS reports on hearing aid accessibility and affordability,…

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buchanan cosponsor hearing aid bill

Florida Congressman the Latest to Co-Sponsor OTC Legislation, Despite Negative Ad Campaign Targeting GOP Supporters

LONGBOAT KEY, FLORIDA — Congressman Vern Buchanan announced yesterday in a press release that he has co-sponsored the Over-the-Counter Hearing Aid Act to help make hearing aids more affordable for seniors. In the announcement the congressman noted how approximately 50 million people in the US have hearing loss, which is a problem that is particularly…

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