OTC hearing devices are coming, but how should they function and for whom should they be recommended? Drs Ron Leavitt, Ruth Bentler, and Carol Flexer present six case studies showing that people with true moderate hearing loss may not be well served by what has been characterized as a “consumer-decides” model of care.
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Now that we’ve defined (at minimum) what an OTC hearing device should look like, maybe it’s time to start defining a minimal standard for what a professional hearing aid fitting should look like.
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Given that the Over-the-Counter (OTC) Hearing Aid Act of 2017 is now law and a new FDA class of OTC hearing aids will be established by the end of 2020, “efforts should now focus on ensuring that older adults also have access to affordable hearing care services,” write Nicholas Reed, Frank Lin, and Amber Willink, PhD, in the September 13 “JAMA Network.”
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It’s time to clearly distinguish professional service from self-service by showing why licensed hearing care professionals can make a huge difference in hearing aid outcomes. Let’s commit to getting consumers a list of essentials by creating a voluntary standard protocol for every licensed professional who dispenses hearing aids. Let’s spell out what consumers should expect. And then let’s promote the hell out of it.
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The Hearing Industries Association (HIA) has announced its endorsement of the five recommendations made in the consensus paper by AAA, ADA, ASHA, and IHS titled, “Regulatory Recommendations for OTC Hearing Aids: Safety & Effectiveness”.
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The unprecedented consensus statement from four national hearing care professional organizations recommends the new FDA classification be called “Self-fit OTC hearing devices.” The paper recommends the new class be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one 510(k) filing for initial FDA approval to ensure the basic safety and efficacy of the device.
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With the deadline for the FDA to publish guidelines related to over-the-counter (OTC) hearing aids looming—the government agency has until 2021, but some say it may be as early as the middle of 2019—many are wondering how that will affect the six major global hearing aid companies.
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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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