Institutional Experience With Cochlear Implants Falling Under the 2020 FDA Corrective Action
Institutional Experience With Cochlear Implants Falling Under the 2020 FDA Corrective Action
复制标题
2020 年 FDA 纠正行动中人工耳蜗植入的机构经验
DOI：
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发表时间：
2022
影响因子：
2.1
通讯作者：
Maura K. Cosetti
中科院分区：
文献类型：
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作者：
Z. Schwam;Enrique R. Perez;Lisa Goldin;Kevin Wong;Caleb J. Fan;Samuel J Oh;G. Wanna;Maura K. Cosetti
目的确定2020年美国食品药品监督管理局（FDA）自愿纠正措施下人工耳蜗植入体的器械故障率。研究设计回顾性病历审查。设置三级耳科-神经耳科实践。人工耳蜗植入失败属于FDA纠正措施范围的患者。干预措施：取出植入物并重新植入。结果测量人工耳蜗植入失败的原因、失败时间、失败症状和再植入的获益。结果失败率为20.0%（18/90耳），其中15/18耳（83.3%）为硬器械失败，3/18耳（16.7%）为内科或外科失败。所有硬器械失效均通过公司进行的完整性测试得到证实。完整性测试的平均时间为38.0个月。在硬失败中，15例中有14例成功初始激活并获益。15例中有7例没有取得预期进展，8例功能突然下降。电极9至16最常失效。在设备故障的情况下，经常看到语音感知的显着下降。排除了3例医疗/手术失败; 1例接收器/刺激器移位导致不适，另外2例在部分插入后电极移位。在重新植入的患者中，12名患者中有11名受益于他们的新器械。结论在我们的系列中，感兴趣的人工耳蜗植入体的器械失效率明显高于最初FDA自愿现场纠正措施出版物中报告的器械失效率。
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.