In a segment on CBS News’ ‘Sunday Morning’ show, contributor and Yahoo Finance tech critic David Pogue examines the low rate of hearing aid adoption in comparison to the percentage of people over 70 with hearing difficulties.
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The company is bullish on the prospects of the upcoming OTC hearing device regulations from FDA, which it anticipates being issued this November and implemented in mid-2020. In his comments to investors, IntriCon CEO Mark Gorder was also optimistic that the new OTC hearing device regulations would be more liberal relative to the amount of allowable gain and for whom the devices might be intended.
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On the eve of major changes in the regulations governing the distribution of hearing aids in the United States, including the new upcoming class of over-the-counter (OTC) hearing devices, MT10 looks at consumers’ perceptions about hearing aids and personal sound amplification products (PSAPs)—as well as their attitudes about OTC devices and do-it-yourself hearing care.
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Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.
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Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.
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It now appears the “OTC regulatory debate” could potentially follow the same general timeframe as the 2020 presidential race—starting with proposed rules by the FDA in November of this year.
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Mead Killion, PhD, provides his perspective on the audiograms used in two studies that look at the suitability of personal sound amplification products (PSAPS) for people with hearing loss in various delivery models.
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Larry Humes, PhD, explains the reasoning behind why the vast majority of participants in his group’s recent study related to OTC hearing aids had near-normal or mild hearing loss, as pointed out by a December 2018 “Hearing Review” article by Ron Leavitt, Ruth Bentler, and Carole Flexer.
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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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