Tag: OTC hearing aid



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.

HIA Reasserts Position on Over-the-Counter Hearing Aids

The Hearing Industries Association (HIA)—the national trade association for manufacturers of hearing aids—believes that if the U.S. Food and Drug Administration (FDA) creates an Over-the-Counter (OTC) hearing aid category as required by legislation now under consideration in Congress (S.670/H.R.1652), such medical devices should meet the same FDA standards as existing hearing aids and should be offered only to people with mild hearing loss, HIA announced.

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OTC Hearing Aid Act Bundled with MDUFA; Expected to Pass through Committee

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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The Effectiveness of Hearing Aids and Two Service-Delivery Models in Older Adults: A Randomized Double-Blind, Placebo-Controlled Clinical Trial

Larry Humes, PhD, and colleagues present a summary of findings from their recent study published in the March 2017 edition of the American Journal of Audiology that compares a professionally driven best-practice hearing aid service delivery model to a version of an over-the-counter (OTC) model. One important message that should not be lost in the extremely relevant findings of this RCT study is that hearing aids are, in fact, efficacious and provide considerable benefit to older adults with mild-to-moderate hearing loss.  

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OTC and Observations on the Humes et al Study

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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Over-the-Counter Hearing Aid Act of 2017 Introduced in Congress

The Over-the-Counter Hearing Aid Act of 2017 was introduced Monday, March 20. The reintroduced legislation is designed to make hearing aids for those with mild-to-moderate hearing loss available over the counter (OTC), and require the FDA to write regulations ensuring the new OTC category meets the same high standards for safety, consumer labeling, and manufacturing protections as all medical devices, providing consumers the option of an FDA-regulated device at lower cost.

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