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Pubmed for Handhelds

PUBMED FOR HANDHELDS

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  • Title: Medical devices; ear, nose, and throat devices; classification of the wireless air-conduction hearing aid. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2011 Jun 15; 76(115):34845-7. PubMed ID: 21675382.
    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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