Search Results for: otc

MarkeTrak 10: Hearing Aids in an Era of Disruption and DTC/OTC Devices

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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Preparing for OTC Hearing Aids

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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Preparing for OTC Hearing Aids

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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Evaluating Select Personal Sound Amplifiers and a Consumer-Decision Model for OTC Amplification

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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After OTC, Focus Should Be on Clinical Hearing Services, Says ‘JAMA’ Article

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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OTC Hearing Aid Consensus Statement Published by AAA, ADA, IHS, and ASHA

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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FDA Issues Letter to “OTC Hearing Aid” Manufacturers

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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NAL, CAEPs, OTC Hearing Aids, and More: An Interview with Brent Edwards, PhD

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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