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A Prospective Multicenter Post-Market Study Evaluating the Safety and Effectiveness of Cochlear Implantation in Adults With Single-Sided Deafness.

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Related Experiment Video

Updated: Aug 12, 2025

Systematic Hearing Performance Evaluation Process for Adolescents with Cochlear Implantation at Early Ages
06:04

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Published on: March 24, 2023

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Institutional Experience With Cochlear Implants Falling Under the 2020 FDA Corrective Action.

Zachary G Schwam1, Enrique Perez1, Lisa Goldin2

  • 1Department of Otolaryngology-Head and Neck Surgery, Icahn School of Medicine at Mount Sinai.

Otology & Neurotology : Official Publication of the American Otological Society, American Neurotology Society [And] European Academy of Otology and Neurotology
|February 2, 2023
PubMed
Summary

Cochlear implant device failures occurred at a 20% rate, with most being hard device failures. Reimplantation offered significant benefit, highlighting the need for vigilance with these FDA-action devices.

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Last Updated: Aug 12, 2025

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Area of Science:

  • Otolaryngology
  • Biomedical Engineering
  • Medical Device Technology

Background:

  • The 2020 Food and Drug Administration (FDA) issued a voluntary corrective action for specific cochlear implant models.
  • Understanding the real-world device failure rates is crucial for patient management and future device development.

Purpose of the Study:

  • To determine the device failure rate of cochlear implants subject to the 2020 FDA voluntary corrective action.
  • To analyze the reasons for failure, timing, symptoms, and outcomes of reimplantation.

Main Methods:

  • Retrospective chart review of patients with cochlear implant failure.
  • Analysis of device explantation and reimplantation data.
  • Integrity testing for hard device failures.

Main Results:

  • An overall device failure rate of 20.0% (18/90 ears) was observed.
  • Hard device failures accounted for 83.3% (15/18), with integrity testing confirming company findings.
  • Reimplantation provided benefit in 11 of 12 patients, with significant drops in speech perception noted in failure cases.

Conclusions:

  • The observed cochlear implant device failure rate in this series is higher than initially reported by the FDA.
  • Hard device failures were the predominant type, often presenting with a sudden decline in function or lack of progress.
  • Reimplantation is a viable option, with most patients benefiting from new devices.