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Otology/Neurotology

(034) Analysis of 20,681 FDA MAUDE Cochlear Implant Medical Device Reports

Monday, October 2, 2023
2:45 PM – 3:45 PM East Coast USA Time
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    Presenting Author(s)

  • AR

    Ashwin Reddy, BS

    Medical Student
    The Johns Hopkins University School of Medicine
    Baltimore, MD, USA

    • Co-Author(s)

  • Arjun Kumar Menta, BSA, BBA

    Medical Student
    The Johns Hopkins University School of Medicine
    Baltimore, Maryland, United States

    • Co-Author(s)

  • Dianela Perdomo, BSc

    Medical Student
    The Johns Hopkins University School of Medicine
    Baltimore, Maryland, United States

  • Andy S. Ding, MD MSE

    Resident Physician
    Department of Otolaryngology - Head and Neck Surgery, Johns Hopkins
    Baltimore, Maryland, United States

    • Senior Author(s)

  • Francis X. Creighton, Jr., MD

    Assistant Professor
    Department of Otolaryngology – Head & Neck Surgery, Johns Hopkins
    Boston, MA, United States

Disclosure(s):
Arjun Kumar Menta, BSA, BBA: No relevant relationships to disclose.
Dianela Perdomo, BSc: No relevant relationships to disclose.
Andy S. Ding, MD MSE: No relevant relationships to disclose.


Introduction: With the ground-breaking innovation of cochlear implant (CI) technology in delivering auditory signals to the cochlear nerve, there has been an increasing prevalence and demand for CIs in the clinical setting. However, there are reports of infection, device failure, and hearing impairment associated with CIs. Therefore, we investigated the medical device reports (MDRs) from the FDA’s Manufacturer and User Facility Database (MAUDE) to better understand the scope of adverse events associated with CIs.

Methods: Retrospective data on adverse events was collected from the FDA’s MAUDE database between 01/01/2018 – 01/29/2023 from the 3 largest CI manufacturers: Med-El, Advanced Bionics, and the Cochlear Corporation. Event descriptions, device problems, and correlated patient problems were grouped and preliminarily analyzed.

Results: 20,681 MDRs met the inclusion criteria, with 14,270 (69%) MDRs having an appropriate device or use problem identification. The most common adverse event concerned Output Failure (23%, n=3286), followed by device problems with Impedance (13%, n=1903), Migration (4%, n=636), Expulsion (4%, n=577), and Circuit Failure (2%, n=332). Other device-related adverse events included Fluid or Blood Leak, Dislodgement, and Triggering Rejection. Across all MDRs, the most prevalent patient-related complications included Failure of Implant (36%, n=5206), Hearing Impairment (9%, n=1290), Pain (5%, n=646), Infection (4%, n=554), and Head Injury (2%, n=317). By manufacturer, the most common adverse event was Expulsion (13%, n=1088) for the Cochlear Corporation (40% of all MDRs, n=8284), Impedance Problems (26%, n=1903) for Advanced Bionics (35% of all MDRs, n=7245), as well as Output Failure (62%, n=3171) for Med-El (25% of all MDRs, n=5152).

Conclusions: While subject to reporting and learning curve biases, the MAUDE database underscores information not ubiquitously captured in literature. Ultimately, the collected outcomes provide unique clinical perspective for prioritizing risk, improving patient counseling, and fostering research to address reported complications.