(835) Early Post-Market Adverse Events Associated with the SENTIO Bone-Anchored Device - A MAUDE Database Analysis

Introduction: The SENTIO device is a transcutaneous bone-anchored hearing apparatus with recent Food and Drug Administration (FDA) approval in 2024. However, few studies have critically examined the post-market safety profile. This study aims to characterize adverse events associated with the SENTIO device reported through the Manufacturer and User Facility Device Experience (MAUDE) database curated by the FDA. Preliminary post-market surveillance is crucial for identifying preventable safety concerns during adoption of implantable hearing devices.

Methods: This retrospective review analyzed all reports submitted to the MAUDE database for the SENTIO device from 2024 to 2025. Event characteristics and secondary interventions were examined for initial trends. The MAUDE database has limitations, including underreporting and reporting bias.

Results: Nine unique reports related to the SENTIO device were extracted from the MAUDE database for review. All reports were categorized as “serious injury.” Five reports were associated with post-operative wound infections, all of which required device explantation: two required emergent removal for infection control. Two reports documented device malfunction attributable to surgeon error, including incorrect placement on the temporalis muscle and mishandling during implantation, resulting in component failure. No reports identified any intrinsic device malfunctions during the manufacturer's examination after the incident.

Conclusions: The findings from this study suggest that adverse events with the SENTIO device are limited in early surveillance. However, the analysis underscores the importance of preoperative patient counseling on the risk of infection and the potential need for emergent explantation. These results may inform surgical education and future patient selection.