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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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Notes from an Early-Deafened Musician

The typical image of a musician with hearing loss is someone like Beethoven, who lost his hearing long after spending a lifetime learning, playing, or composing aural music. What is lost in this image is the fact that there are individuals like myself, who acquire significant hearing loss shortly after birth or in early adolescence, yet fall in love with aural music during this same period in their lives.

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