Tag: Class II

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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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