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The Utility of the MAUDE Database in Researching Cochlear Implantation Complications
Arch Otolaryngol Head Neck Surg. 2005;131:251.
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Prior reports on complications associated with cochlear implantation have been, for the most part, generated by individual implant centers or manufacturers. Complication rates reported in these studies may reflect specific surgical practices or devices. In this issue of the ARCHIVES, Tambyraja et al1 review cochlear implant complications as reported to the Manufacturer User Facility and Distributor Experience (MAUDE) database. This database is maintained by the Center for Devices and Radiological Health, an arm of the US Food and Drug Administration (FDA). The MAUDE database contains reports of adverse events associated with medical devices. Tambyraja et al assessed the utility of the MAUDE database in reflecting a broader experience of complications related to implantation.
The authors conclude that spontaneous device failure is the most common complication of cochlear implantation. However, it seems likely that the MAUDE database is skewed for adverse sequelae related to device failure. Complications that can . . . [Full Text of this Article] AUTHOR INFORMATION
Yael Raz, MD
RELATED ARTICLE
Cochlear Implant Complications: Utility of Federal Database in Systematic Analysis
Rabindra R. Tambyraja, Michael A. Gutman, and Cliff A. Megerian
Arch Otolaryngol Head Neck Surg. 2005;131(3):245-250.
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