Background: A new generation of active transcutaneous bone conduction implants (BCI) are available since 2019 and literature comprising technical and medical complications is sparse. The aim of this investigation is to report on medical device reports submitted to FDA MAUDE database to identify adverse events (AEs) in patients implant with novel active BCIs.
Methods: We conducted a search in the FDA MAUDE database using the device model numbers "BCI602 BONE CONDUCTION IMPLANT" (Medel, Innsbruck, Austria) and "COCHLEAR OSIA OSI200 IMPLANT" (Cochlear, Sydney, Australia). We collected data concerning device malfunctions, patient injuries, factors triggering these incidents, and the subsequent actions taken, for the time period from December 1st, 2019 to July 24th, 2023.
Results: In total, 569 AEs were documented, consisting of 89 device malfunctions and 480 patient injuries with 420 subsequent interventions.
No device output (31.3%, n = 20) and loss of osseointegration (10.1%, n = 7) were most often AEs in BCI602 (total of 64 AEs). On the other hand, infection (33.9%, n = 171), extrusion of the device (21.2%, n = 107), and wound dehiscence (8.1%, n = 41) were the most frequently reported AEs for OSI200 (total of 505 AEs). Various AEs led to 237 (56.4%) explanations and 79 (18.8%) revision surgeries. Sixty-eight AEs (16.2%) required conservative treatment.
Conclusion: The current study provides an overview on the most commonly reported complications in first three years of hearing rehabilitation with new active transcutaneous bone-conductions implants BCI602 and OSI200. Although providing a good overview, given the limitations of the FDA MAUDE database, our results have to be interpreted with caution.
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