(A801) Adverse Events Associated with Full Middle Ear Implant: A MAUDE Study

Introduction: Manufacturer and User Facility Device Experience (MAUDE) is an FDA reporting database that requires manufacturers and physicians to report adverse effects of FDA-approved medical equipment. In our study, we analyzed a middle ear implant for severe hearing loss, which was FDA-approved in 2010. Currently, no study has reported adverse events with this device.

Methods: This is a retrospective database study. MAUDE reports from January 1, 2014, to August 1, 2024, were searched for. 138 reports were analyzed for adverse events, including patient-related and device-related.

Results: There were 190 unique adverse events. 121 (63.7%) were patient-related, while 69 were device malfunctions (36.3%). Out of the 121 patients with adverse events, 48% presented with hearing disturbances, 31% presented with wound dehiscence, and 14% presented with post-operative infections. 29% of the device malfunctions were due to battery insufficiency, 24.6% electrical feedback or intermittency, 14.5% impeded connectivity, and 13% malfunctioned with no identified root cause. 21% of the reports were resolved by explant, 15.4% required revision, 14.5% had sound processor replacement, 12.7% battery replacement, and 11.8% device replacements.

Conclusions: This study presents the adverse effects of an FDA-approved middle ear implant, as reported in MAUDE. Due to MAUDE’s database limitations, we cannot draw definitive conclusions. However, we provide a reference for the common reasons behind MAUDE adverse event reporting. MAUDE reporting needs to be standardized to elevate the quality of reports for analysis.