Category: Over the Counter

Over the Counter

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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.

HHTM Releases New Book, ‘Interpersonal Audiology,’ by Brian Taylor, AuD

In the ”New Age” of patient autonomy—as persons with hearing loss increasingly have the ability to self-direct their care by testing and purchasing hearing devices over-the-counter—counseling and customization are components that still require a human element, and at the heart of this human element is Interpersonal Audiology.

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NationsHearing Unveils New Hearing Technology at CES 2019

In addition to providing hearing aids from most of the major hearing aid manufacturers, NationsHearing is announcing that they are the exclusive provider of all products designed, developed, and manufactured by Olive Union, a manufacturer of next-generation hearing aids and hearables that use smart-sound algorithms and Bluetooth technology.

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Letters: Hearing Loss Severity and OTC Hearing Aids: Larry Humes Comments on Article by Leavitt, Bentler & Flexer

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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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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FDA Announces Revamping of Product Approvals and 510(k) Program

The FDA has announced it will be modernizing its 510(k) clearance pathway, which accounts for the majority of devices that the Agency reviews, in what it characterizes as a “generational change.” Specifically, the Agency says it will concentrate on more recent predicates and technological advances in its future decision-making process, and ramp up its post-market surveillance of products.

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