A letter by the FDA’s William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.
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Brent Edwards, PhD, who has recently been appointed director of the National Acoustic Laboratories (NAL) research center in Sydney, Australia, is interviewed by Douglas Beck, AuD, in this edition of “HR’s“ Inside the Research. Topics include research at NAL, the NAL’s cortical auditory evoked potential (CAEP) system known as HEARLab, over-the-counter hearing aids, and more.
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iHEAR will launch the TReO, what the company says is the “first prescription-quality hearing amplifier for OTC markets,” and the iHearTest kit, a FDA-cleared home hearing screener, in 500 drugstores in June 2018.
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I predict that a number of problems will need to be solved so that a consumer can pick up an over-the-counter hearing assistance product and have it work as well as a ballpoint pen does for most of us.
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Now that the political hay has been harvested, the real business of affordable and accessible hearing care is on the table and at your mercy.
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The center of conversation at this year’s ADA Convention was what impact OTC hearing devices would have on the market, their pros and cons, and how best to prepare a practice for changes in the wake of the OTC Hearing Aid Act of 2017.
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The debate now moves from “if” an OTC class of hearing devices should exist to “what” that OTC class will look like.
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Following the announcement of the passage of the legislation into law, several organizations released statements supporting the bill.
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On Friday, August 18, President Donald Trump signed into law today the Food and Drug Administration Reauthorization Act of 2017, legislation that includes the Over the Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. FDA will now be charged with creating and regulating a new class of OTC hearing aids.
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The online survey was conducted between August 1 and August 8, 2017, reportedly for the purpose of exploring the views of audiologists on the subject of over-the-counter (OTC) hearing aids. A total of 566 US-based audiologists completed the survey.
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William Demant—parent company of Oticon, Sonic, and Bernafon—said it would start producing over-the-counter hearing aids if customer demand increases after passage of the Over-the-Counter Hearing Aid Act.
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The US Senate passed the FDA Reauthorization Act of 2017—which includes the Over-the-Counter (OTC) Hearing Aid Act of 2017—by a vote of 94-1, on August 3.
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Larry Humes, PhD, responds to the July 2017 Hearing Review article by John Tecca, which addressed Dr Humes recent article about OTC hearing aids in the American Journal of Audiology and a summary article in the May 2017 Hearing Review.
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The Over the Counter Hearing Aid Act (HR 1652), which was bundled as part of the Medical Device User Fee Amendments (MDUFA) package and the FDA Reauthorization Act, was passed yesterday by the US House of Representatives as anticipated.
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In the article, Sawalich says, “Like a thumb print, every ear and hearing loss is unique,” and stresses the vital role that hearing care professionals play in the diagnosis and evaluation of hearing loss.
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