Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule.

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.

Citation

Food and Drug Administration, HHS. Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule. Federal register. 2011 Jun 15;76(115):34845-7

Mesh Tags

PMID: 21675382

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