HiRes ultra series cochlear implant field recall: failure rates and early outcomes
HiRes ultra series cochlear implant field recall: failure rates and early outcomes
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HiRes ultra 系列人工耳蜗现场回顾：失败率和早期结果
DOI：
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发表时间：
2022
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通讯作者：
D. Jethanamest
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文献类型：
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作者：
A. Winchester;E. Kay;D. Friedmann;S. Mcmenomey;W. Shapiro;J. Roland;S. Waltzman;D. Jethanamest
目的评估在全球设备召回的背景下，先进仿生超三维/超音速人工耳蜗术后的失败率，并报告翻修后的手术和听觉结果。方法对2016~2020年在我中心植入高危装置的成人和儿童患者进行回顾性分析。记录并分析器械失败率、手术和听力结果。结果在113个高危装置中，18例患者的20个装置(17.7%)(两个双侧植入)被确定为故障。所有装置均采用Scala中段电极。儿童11例(61.1%)，成人7例(38.9%)。12名患者在报告主观性能下降后被发现设备故障；其余的患者是由制造商通知引起的。所有都进行了修改，大多数(83.3%)选择了相同的制造商。所有版本都有简单的原版和修订版插页。在成人中，修订前和修订后的平均单词分数是稳定的(P = 0.95)。讨论由于这种磁场作用而导致装置失效的患者在翻修植入后表现良好。有双侧危险装置但有单侧失败证据的患者可以选择同时接受对侧装置的经验性翻修。三名在修订时选择更换设备制造商的患者的结果不同，需要进一步调查。结论：需要翻修器械野动作的患者总体表现良好。风险设备继续需要监控，因为随着时间的推移，可能会有越来越多的设备出现故障。
Objective Evaluate rates of Advanced Bionics Ultra 3D/Ultra cochlear implant failure in the setting of a worldwide device recall and report surgical and auditory outcomes after revision. Methods Retrospective chart review was performed for adult and pediatric patients implanted with at risk devices at our center from 2016 to 2020. Device failure rates, surgical, and auditory outcomes were recorded and analyzed. Results Of 113 at-risk devices, 20 devices (17.7%) in 18 patients (two bilaterally implanted) were identified as failures. All devices were with mid-scala electrodes. Eleven patients (61.1%) were children and 7 (38.9%) adults. Twelve patients were found to have failing devices after reporting subjective performance decline; the remainder were prompted by manufacturer notification. All were revised, with the majority (83.3%) choosing the same manufacturer. All had uncomplicated original and revision insertions. Among adults, average word scores on the revised side were stable pre- to post-revision (P = 0.95). Discussion Patients with device failure due to this field action performed well after revision implantation. Patients with bilateral at-risk devices but evidence of unilateral failure may elect to undergo simultaneous empiric revision of the contralateral device. Three patients who elected to change device manufacturers on revision have variable results that require further investigation. Conclusions Patients requiring revision for a device field action overall perform well. At-risk devices continue to require monitoring as a growing number are likely to fail over time.