The Utility of the MAUDE Database for Osseointegrated Auditory Implants.

OBJECTIVE To determine the utility of Manufacturer and User Friendly Device Experience (MAUDE) database in studying osseointegrated auditory implant (OAI)-related complications. METHODS The MAUDE database was searched for all reports involving OAIs (ie, Baha, Ponto, Sophono). Complications were classified into 1 or more of 6 categories-implant, abutment, processor, skin, surgery, and other. Subcategories were generated to prevent overgeneralization. Other variables recorded included date of report, number of complications per report, manufacturer, and time from complication to report. RESULTS Over the study period, there were 269 complications listed from 238 reports divided into the following categories: implant related (n = 145), abutment related (n = 16), processor related (n = 13), skin and soft tissue related (n = 79), surgery related (n = 11), and other (n = 5). No demographic data were available. There were no discernible trends from the data, and when compared to published literature, MAUDE data appear to under- or misrepresent complications. CONCLUSION The MAUDE database is limited in its design and given fairly disparate reporting quality may not be ideally suited for quantifying risks of OAIs. These findings suggest the necessity for a substantially improved central registry for otologic implants and highlight the need for further research to investigate the root causes of their associated complication.