A MAUDE database analysis on the new generation of active bone conduction hearing implants
Alexander Lein,
Wolf‐Dieter Baumgartner,
Lukas D. Landegger
et al.
Abstract:ObjectiveTo analyze medical device reports (MDR) submitted to the Food and Drug Administration's (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events (AEs) in patients implanted with novel active bone conduction hearing implants (BCIs).MethodsWe conducted a search of the FDA MAUDE database on the newest generation of BCIs. Data were collected concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken.Resul… Show more
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