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Video

Otology/Neurotology

(A843) MRI-Related Adverse Events for Cochlear Implants: A MAUDE Database Study

Monday, October 13, 2025
12:00 PM - 1:00 PM EDT
Location: OTO EXPO, Posters
Has Audio

    Presenting Author(s)

  • Christopher Hyland, BS

    Medical Student
    Northeast Ohio Medical University
    Cleveland, Ohio, United States

    • Senior Author(s)

  • Anita S. Jeyakumar, MD, MS

    Director Otology and Cochlear Implant Programs
    NEOMED, HEARS, LLC
    Akron, Ohio, United States

    • Co-Author(s)

  • QL

    Quan Lu, BA

    Medical Student
    Northeast Ohio Medical University
    Rootstown, Ohio, United States

Disclosure(s):
Christopher Hyland, BS: No relevant relationships to disclose.
Anita S. Jeyakumar, MD, MS: No relevant relationships to disclose.
Quan Lu, BA: No relevant relationships to disclose.


Introduction: Evaluation of cochlear implant (CI) adverse event reports (AERs) related to magnetic resonance imaging. Emphasis on overall trends and within/between manufacturers.

Methods: IRB approval was obtained and retrospective review of CI records from the MAUDE database between 1 January 2014 to 31 December 2023 was performed. MRI-related AERs were identified using keyword searches. Data was organized according to year and manufacturer: Manufacturer A (Cochlear Limited), Manufacturer B (Med-El) and Manufacturer C (Advanced Bionics). Records were further sub-classified by adverse event type and device model. Analysis of data was performed using descriptive and inferential statistics. Individual manufacturer AER rates were calculated using percentage of MAUDE reports for each company and stratified by year.

Results: 780 AERs were identified across all three manufacturers and represent 3.9% of total reports from Manufacturer A, 0.13% of reports from Manufacturer B, and 1.2% of reports from Manufacturer C. The most frequent adverse events identified included: magnet dislodgement during MRI (84.5%), pain during/following MRI (6.9%), and flipped magnet/reversed polarity (4.2%). Of note, 14.2% of AERs indicated that proper device-related MRI precautions were not followed when patients underwent imaging. ANOVA testing determined a significant difference in the average yearly percentage of AERs returned from MAUDE between manufacturers (p < 0.001). Negative binomial regression showed an average yearly increase of 13% (95% confidence interval, 2%-25%) in the share of MAUDE MRI-related AERs across all manufacturers (p=0.019).

Conclusions: Analysis of MAUDE AERs can highlight noteworthy trends and reinforce the importance of clear and proper MRI guidelines for the cochlear implant population. Definitive conclusions regarding manufacturer safety and accuracy of figures must be approached with caution given the often-incomplete and limited nature of MAUDE data.