Category: Regulation



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.

New Bills in California, Nevada Aim to Make Hearing Aid Coverage for Children Mandatory

Legislators in both California and Nevada have introduced bills to make it mandatory for insurers to cover the cost of hearing aids for children, according to articles in the “Santa Monica Daily Press” and “Las Vegas Review-Journal.”

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Merger between Widex and Sivantos Receives Final Clearance from European Commission

The newly created company will be a global leader with a presence in more than 125 markets, combined revenues of more than EUR 1.7 billion (about $1.92 billion USD) and more than 10,000 employees worldwide. All Widex and Sivantos brands will continue to operate with separate sales forces and organizations following the combination.

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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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AG Bell Publishes FAQ Addressing Controversial LEAD-K Bill

In late October, AG Bell and LEAD-K (Language Equality and Acquisition for Deaf Kids) leaders agreed on adaptations to the controversial model LEAD-K bill that the organizations say is designed to allow parents to continue to receive balanced and comprehensive information about language acquisition in and Spoken Language and American Sign Language (ASL) for their children. Last week, AG Bell released an FAQ document further clarifying its position.

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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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FCC Proposes Automating Phone Captioning

As part of a July 18 announcement in the Federal Register on a new proposed ruling, the Federal Communications Commission (FCC)—the government agency regulating interstate communications by radio, TV, satellite, cable, and wire—has indicated an interest in utilizing automated speech recognition (ASR) as an alternative to live captioning assistants (CAs) for Internet Protocol Captioned Telephone Service (IP CTS), making the use of CAs optional.

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