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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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Composing with Hearing Loss

Composing music when you have a severe hearing loss can be a real challenge. For example, one has to listen with high acuity to the musical tracks using headphones or in-ear monitors that, by nature, make hearing aid use very difficult or impossible. Here are some insights from an accomplished composer who has devised several solutions for the creation of great music.

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Loss Plus Correction Equals Baseline

Recommendations for a “Musicians’ Package” for Hearing Aid Users: A Smartphone app that has a 5- or even 10-band equalizer to modify music output. It should also be able to enable or disable automatic controls easily, such as feedback and attenuation levels, without a visit to the audiologist.

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