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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In this commentary post on Hearing Review’s blog, ASHA President Jaynee Handelsman, PhD, CCC-A, explains why recommendations by the National Academy of Sciences and PCAST are off the mark, and could lead to increased problems in hearing health.
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Among a dozen recommendations, the Committee on Accessible and Affordable Hearing Health Care for Adults would like to see the FDA establish an over-the-counter class of hearing devices, an end to the “waiver system,” hearing aids that have open programming, and portability of consumers’ audiograms and hearing aid programming information.
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iHear Medical announced that it received FDA clearance for the iHearTest, the first hearing test approved for over-the-counter (OTC) sales. The iHearTest is intended to profile hearing ability based on WHO guidelines, targeting adults who suspect they have hearing loss, or those reluctant to seek professional evaluation for a basic hearing assessment.
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In a public comment before the President’s Council on Science and Technology (PCAST), ASHA expressed grave concern and opposition to the Council’s recent recommendations related to accessibility to and affordability of hearing health care services. The PCAST recommendations included a new FDA classification of over-the-counter (OTC) hearing aids.
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The President’s Council of Advisors on Science and Technology (PCAST) held an open teleconference on October 23, 2015 to discuss its report, “Aging America & Hearing Loss: Imperative of Improved Hearing Technologies.” Among the PCAST’s recommendations are a distinct FDA category for “basic” OTC hearing aids without the requirement for consultation with a credentialed dispenser, and the FDA’s withdrawal of its draft guidance document regarding personal sound amplification devices (PSAPs), referring instead to this new category as “devices for discretionary consumer use.” The Hearing Industries Assn (HIA) strongly disagrees with the PCAST and says it will be responding to the numerous errors in the report.
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According to new research findings, blocking the Notch pathway that controls hair cell distribution in the inner ear may help determine cochlear progenitor cell proliferation capacity.
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