PDF(Pubmed)
Abstract：
This multi-center study examined the safety and effectiveness of cochlear implantation of children between 9 and 11 months of age. The intended impact was to support practice regarding candidacy assessment and prognostic counseling of pediatric cochlear implant candidates. Data in the clinical chart of children implanted at 9-11 months of age with Cochlear Ltd devices at five cochlear implant centers in the United States and Canada were included in analyses. The study included data from two cohorts implanted with one or two Nucleus devices during the periods of January 1, 2012-December 31, 2017 (Cohort 1, n = 83) or between January 1, 2018 and May 15, 2020 (Cohort 2, n = 50). Major adverse events (requiring another procedure/hospitalization) and minor adverse events (managed with medication alone or underwent an expected course of treatment that did not require surgery or hospitalization) out to 2 years post-implant were monitored and outcomes measured by audiometric thresholds and parent-reports on the IT-MAIS and LittlEARS questionnaires were collected. Results revealed 60 adverse events in 41 children and 227 ears implanted (26%) of which 14 major events occurred in 11 children; all were transitory and resolved. Improved hearing with cochlear implant use was shown in all outcome measures. Findings reveal that the procedure is safe for infants and that they show clear benefits of cochlear implantation including increased audibility and hearing development.
摘要：
这项多中心研究检查了9至11个月大的儿童人工耳蜗植入的安全性和有效性。预期的影响是支持有关儿科人工耳蜗候选人的候选人资格评估和预后咨询的实践。分析中包括了在美国和加拿大的五个人工耳蜗植入中心使用人工耳蜗有限公司设备在9-11个月大的儿童的临床图表中的数据。该研究包括2012年1月1日至2017年12月31日（队列1，n=83）或2018年1月1日至2020年5月15日（队列2，n=50）期间植入一个或两个Nucleus设备的两个队列的数据。监测植入后2年内的主要不良事件（需要另一次手术/住院治疗）和次要不良事件（单独使用药物治疗或接受不需要手术或住院的预期疗程），并通过听力测定阈值和父母报告来衡量结果收集IT-MAIS和LittlEARS问卷。结果显示，41名儿童发生了60起不良事件，植入了227只耳朵（26％），其中11名儿童发生了14起主要事件；所有事件都是暂时的并已解决。所有结果指标均显示使用人工耳蜗改善听力。研究结果表明，该程序对婴儿是安全的，并且它们显示出人工耳蜗植入的明显益处，包括增加的听觉和听力发育。
