American journal of otolaryngology | 2021
Adverse events associated with Bonebridge and Osia bone conduction implant devices.
Abstract
PURPOSE\nActive transcutaneous Bone Conduction Implants (BCIs) are relatively new to the market and may offer improved outcomes while reducing skin-related complications associated with previous models. The purpose of this study is to examine medical device reports (MDRs) submitted to the Food and Drug Administration s (FDA) Manufacturer and User Device Facility Experience (MAUDE) database to identify adverse events with the active, transcutaneous BCIs, Bonebridge and Osia.\n\n\nMETHODS\nA search of the FDA MAUDE database was conducted using product code PFO (for Active Implantable Bone Conduction Hearing System), brand names Bonebridge and Osia. Data was collected on device malfunction, patient injury, inciting events, and subsequent interventions between July 1, 2018 and November 1, 2020.\n\n\nRESULTS\nThe search query yielded 83 reports that met inclusion criteria, 56 regarding Bonebridge and 27 regarding Osia. A total of 91 adverse events were reported, including 45 device malfunctions and 46 patient injuries. Of all adverse events, 15 (32.6%) patient injuries were reported with Bonebridge use compared to 31 (67.4%) patient injuries with Osia use, whereas 42 (93.3%) of the device malfunctions were reported for Bonebridge and 3 (6.7%) were reported for Osia. The most commonly reported adverse events included lack of conduction or hearing (n\xa0=\xa026, 28.6%), infection (n\xa0=\xa014, 15.4%), and intermittent or reduced conduction or hearing (n\xa0=\xa012, 13.2%). We estimate patient injuries to occur in 2.1% of patients implanted with Osia over a 28\xa0month period.\n\n\nCONCLUSION\nThere are limitations to the database which make systemic analysis challenging. This study suggests that patients with transcutaneous, active BCIs may be experiencing fewer soft tissue injuries, but similar device malfunctions as those with previous models.