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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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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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New Self-fitting Hearing Aid Class and Special Controls Described by FDA Letter

The FDA has concluded that the Bose Hearing Aid should be classified as a Class II device under the generic name “self-fitting air-conduction hearing aid,” according to an October 5 letter from the Agency. Accordingly, Bose is free to market the device immediately subject to general provisions and special controls required by FDA. Subsequent applications for a self-fitting hearing aid will need to undergo premarket notification requirements, according to the Agency.

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