A MAUDE database analysis on the new generation of active bone conduction hearing implants

Area of Science:

• Otolaryngology
• Biomedical Engineering
• Medical Device Safety

Background:

• Novel active bone conduction hearing implants (BCIs) offer improved hearing solutions.
• Understanding the safety profile and adverse events (AEs) associated with these devices is crucial for patient care and device development.

Purpose of the Study:

• To 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).

Main Methods:

• A search of the FDA MAUDE database was conducted for the newest generation of BCIs.
• Data collected included device malfunctions, patient injuries, triggering factors, and subsequent actions.
• Analysis focused on identifying trends in AEs and their management.

Main Results:

• A total of 558 AEs were identified, with 83.3% related to patient injuries and 16.7% to device malfunctions.
• For the OSI200 implant, infection (34.6%), device extrusion (21.7%), and pain (10.3%) were the most reported AEs.
• For the BCI602 implant, no device output (31.3%) and loss of osseointegration (10.9%) were the most frequently reported AEs.

Conclusions:

• This study provides an overview of common complications associated with new active BCIs.
• Results highlight the need for careful patient selection and post-operative monitoring.
• The findings should be interpreted with caution due to the inherent limitations of the FDA MAUDE database.