Category: Regulation

Regulation

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Eargo, DOJ Reach Settlement on Reimbursement Investigation

In line with the Company’s priority to regain insurance coverage of Eargo for government employees under the FEHB program, the Company is focused on enhancing its compliance and risk management processes with respect to its operations in the healthcare industry and hiring additional qualified personnel and specialized consulting resources before submitting any further claims.

Regulation

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Sens. Grassley, Warren Support FDA Rule on OTC Hearing Aids

In a letter to US Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, Sens. Chuck Grassley (R-Iowa) and Elizabeth Warren (D-Mass.) expressed their support for key provisions in the FDA’s proposed rule for regulating over-the-counter (OTC) hearing aids.

Regulation

Latest

FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.

Managing Managed Care

Managed care is substantially growing in depth and breadth every year. Telehealth, OTC, the current pandemic, and other factors significantly impact the modern hearing care office in tandem with managed care. Therefore, as we evaluate, select and participate in managed care, we must seek and select the opportunities which best meet the goals and needs of the modern hearing care office.

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Arizona Attorney General Issues Warning to Consumers About OTC Hearing Aids

Arizona Attorney General Mark Brnovich has issued an announcement on his website cautioning consumers to watch out for “misleading sales tactics from companies selling over-the-counter hearing amplifiers.” Over the past year, the Attorney General’s Office (AGO) said it has received approximately 140 complaints about over-the-counter hearing aids.

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Maintaining Consumer Protections for All Hearing Aids

Three years ago on August 18, 2017, what has become known as the “OTC Hearing Aid Act” was signed into law, and we’ve now reached the statutory deadline for proposed rules for this new class of hearing aid. Although FDA is obviously focused on the COVID-19 pandemic, the complexities of federal preemption of state laws related to hearing aids also loom large. To ensure strong consumer protections, HIA conducted exhaustive research of hearing aid laws in the 50 states, identifying five primary areas of consumer protection to flag for FDA.

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