Search Results for: otc

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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CEDRA: A Consumer Questionnaire to Detect Disease Risk Before Hearing Aid Purchase

To maintain consumer safety while dispensing hearing aids and other amplification devices when licensed providers are not involved, a multidisciplinary research team developed the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire, which is designed to identify the risk of diseases with ear and hearing symptoms. Noted researcher Donald Nielsen, PhD, explains its development and how the self-administered test can be used online for free.

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