According to industry sources, the June 9 dissemination meeting of the National Academies of Sciences, Engineering, and Medicine (NASEM) is expected to include a “strawman” proposal that could serve as a starting point for discussions that lead to an OTC hearing aid category by the FDA.
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iHEAR Medical—a venture-backed firm dedicated to addressing the global need for affordable and accessible hearing solutions—announced that it supports the Over-the-Counter (OTC) Hearing Aid Act of 2017, which was recently introduced in Congress to improve access and affordability of hearing aids.
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The Hearing Industries Association (HIA) has issued a position paper in response to what the organization sees as several inaccurate statements made at the recent April 18 FTC Workshop titled, “Now Hear This.”
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The Over the Counter Hearing Aid Act of 2017 is expected to pass through the Senate Health, Education, Labor & Pensions (HELP) Committee as part of the much larger Medical Device User Fee Amendments (MDUFA) package. Although the current bill continues to allow OTC devices to apply to “mild-to-moderate” hearing losses, the severity of hearing loss remains a primary sticking point for the bill.
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In a signal of growing support for the Over-the-Counter Hearing Aid Act of 2017, the Academy of Doctors of Audiology (ADA), Consumers Union, and the National Committee to Preserve Social Security & Medicare have released letters endorsing the legislation, according to a blog post on Sen Elizabeth Warren’s webpage.
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The FTC held the workshop, “Now Hear This” looking at a myriad of issues surrounding technology and competition in hearing healthcare, as well as how over-the-counter hearing aids might impact customer satisfaction, the use of amplification products, consumer safety, and professional care.
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Perhaps the most well-read article of 2017 is “The effects of service-delivery model and purchase price on hearing-aid outcomes in older adults: a randomized double-blinded placebo-controlled clinical trial” by Larry Humes and his colleagues at Indiana State University, published in the March 2017 edition of the American Journal of Audiology. Drs Marshall Chasin and Steve Aiken provide their perspectives on this important research.
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The merits, drawbacks, and risks associated with over-the-counter (OTC) and mail-order hearing aids and personal sound amplification products (PSAPs) have been debated in earnest for at least three decades—and new research and information continues to shed light on this important topic.
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Clinically we all need to walk the fine line between the “values” of our clientele and the “facts” that we need to impart upon them as professionals. Marshall Chasin discusses this in relation to his own patients, as well as the OTC hearing aid debate.
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The first-ever placebo-controlled, double-blind, randomized clinical trial of hearing aid outcomes shows that older adults benefit from hearing aid use, including over-the-counter (OTC) devices. There were no significant differences in outcome between the OTC and audiology best-practice service-delivery approaches for 5 of the 6 outcome measures, but the OTC group fared somewhat worse when it came to satisfaction with their hearing aids. Fewer OTC participants were also likely to purchase their hearing aids after the trial (55% for the OTC group vs 81% for the best practices group, with 36% for the placebo group).
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The Hearing Industries Association has recommended that, if the FDA creates a new over-the-counter (OTC) category for hearing devices, these products be confined to mild hearing losses and comply with the same safety and efficacy standards required for air-conduction hearing aids. Further, if the OTC category is established, HIA recommends that FDA review and finalize its guidance for PSAPs so these devices cannot be marketed to address hearing loss.
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Signia reports that it is the first to integrate into its hearing aids Notch Therapy for tonal tinnitus—the most common form of tinnitus which involves pure-tone-like whistling, ringing, or humming phantom sounds. The tinnitus therapy features are available in all BTE and ITE aids in the company’s primax platform.
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ADA announces its support of S.9, the Over-the-Counter Hearing Aid Act of 2016. The ADA commends Senators Warren and Grassley for their foresight in introducing and advancing this legislation, which if enacted, will remove “unnecessary and burdensome barriers” to hearing care for millions of Americans.
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US Senators Warren and Grassley will introduce the Over-the-Counter Hearing Aid Act of 2016, which would make certain hearing aids available over the counter (OTC), removing “unnecessary” barriers for many consumers who could benefit from “simpler” devices.
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Brian Taylor and ADA Executive Director Stephanie Czuhajewski provide a counterpoint to a recent Hearing Review editorial by ASHA President Jaynee Handelsman that cautioned against over-the-counter (OTC) hearing devices.
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