Cochlear implant complications: utility of federal database in systematic analysis.

Objectives: To explore the suitability of the Manufacturer User Facility and Distributor Experience (MAUDE) database (which is maintained by the Food and Drug Administration and has a mandatory reporting requirement) for systemic analysis of cochlear implant complications and treatments and, in so doing, analyze trends in cochlear implant complications for 2 periods, 2002 and pre-1998.

Data Sources: All events from 2002 and from before 1998 were considered. Events and action taken were categorized and tabulated.