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March 2005

The Utility of the MAUDE Database in Researching Cochlear Implantation Complications

Arch Otolaryngol Head Neck Surg. 2005;131(3):251. doi:10.1001/archotol.131.3.251

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.

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