Category: Regulation

Regulation

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Sen. Chuck Grassley Holds Q&A in Iowa with HCP

Senator Chuck Grassley's (R-Iowa) office announced that he met with Iowa Audiology President and CEO Dr Jason Aird to discuss the Food and Drug Administration’s (FDA) finalization of a key rule allowing hearing aids to be sold over-the-counter – a “bipartisan effort Grassley has led for over five years.”

Regulation

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Eargo Supports Proposed Rule for OTC Hearing Aids

Eargo, Inc (Nasdaq: EAR), a medical device company on a mission to improve the quality of life of people with hearing loss, announced the submission of public comments to the Food and Drug Administration (FDA) concerning its proposed rule to create a new regulatory category of over the counter (OTC) hearing aids.

FDA Issues Proposed OTC Hearing Aid Rules

To ensure patient safety, the proposed rule addresses maximum output limits and includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits, frequency bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids. As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

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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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