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Bose Receives FDA Class II Designation for Self-fitting Hearing Aid, Favorable ITC Ruling on Headphone Patent Infringement

The FDA published its final order on Bose’s De Novo application for a self-fitting hearing aid. The new hearing aid is a Class II device subject to controls similar to other wireless hearing aids, but with special safety and labeling requirements. This is not to be confused with an “OTC hearing device.” In unrelated news, the US ITC has ruled that several companies have infringed on Bose patents related to the company’s “StayHear” headphone tips.

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