Category: Regulation

Regulation

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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.

Best Practices for Eligibility for Captioned Telephone Services Suggested by AAA and ASHA

Responding to published concerns by the FCC that captioned telephone services (CTS) are being utilized by people who are not appropriate candidates—leading to potential funding deficits of this critical service—the American Academy of Audiology and the American Speech-Language-Hearing Association have jointly developed proposed best practices for determining eligibility for the program.

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Reps. Thompson and McKinley Reintroduce Congressional World Hearing Day Resolution

The resolution, H.Res. 147, highlights the critical role hearing ability plays in personal health, relationships, professional success, education, and safety. The resolution also discusses the important role of professional intervention and evaluation through licensed hearing care providers—hearing aid specialists, audiologists, and otolaryngologists, who can recommend and assist with rehabilitation options, which may include medical intervention or the use of assistive hearing technologies like hearing aids.

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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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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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