Abstract
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
Keywords
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