Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule |
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Authors: | Food and Drug Administration HHS |
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Abstract: | The Food and Drug Administration (FDA) is classifying the wireless air-conduction hearing aid into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. |
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