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

ABSTRACT

OBJECTIVE: To determine the rate of device failure for those cochlear implants falling under the 2020 Food and Drug Administration (FDA) voluntary corrective action. STUDY DESIGN: Retrospective chart review. SETTING: Tertiary otology-neurotology practice. PATIENTS Those with cochlear implant failure falling under the FDA corrective action. INTERVENTIONS: Cochlear implant explant and reimplantation. OUTCOME MEASURES: Reason for cochlear implant failure, time to failure, symptoms of failure, and benefit from reimplantation. RESULTS: The overall failure rate was 20.0% (18 of 90 ears); of the failures, 15 of 18 (83.3%) were hard device failures, and 3 of 18 (16.7%) were medical or surgical failures. All hard device failures were confirmed with integrity testing as performed by the company. The average time to integrity testing was 38.0 months. Of the hard failures, 14 of 15 had successful initial activation and benefit. Lack of expected progress was seen in 7 of 15 and a sudden decline in function in 8 of 15. Electrodes 9 to 16 were most often defunct. Significant drops in speech perception were often seen in device failure cases. Three medical/surgical failures were explanted; one had migration of the receiver/stimulator causing discomfort, and the other two had electrode migration after partial insertion. Of the reimplanted patients, 11 of 12 are deriving benefit from their new devices. CONCLUSIONS: The rate of device failure for the cochlear implants of interest is significantly higher in our series than reported in the initial FDA voluntary field corrective action publication.