Trends in Cochlear Implant Complications: Implications for Improving Long-Term Outcomes
Trends in Cochlear Implant Complications: Implications for Improving Long-Term Outcomes
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DOI：
10.1097/mao.0b013e31827d0943
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发表时间：
2013-02-01
影响因子：
2.1
通讯作者：
Newman, Tracey A.
中科院分区：
文献类型：
--
作者：
Causon, Andrew;Verschuur, Carl;Newman, Tracey A.
目的：回顾世界范围内关于人工耳蜗不良事件的数据，检测10年来的显著趋势，并讨论这些趋势背后的可能原因。评估制造商和用户设施设备体验（MAUDE）数据库用于分析人工耳蜗不良事件趋势的适用性。研究设计：回顾性分析向美国食品和药物管理局（FDA）报告的MAUDE数据库中记录的人工耳蜗不良事件。对2000年（n = 237）、2005年（n = 1089）和2010年（n = 2543）报告的每种不良事件的数据进行评估，并根据报告内容将其划分为14个类别之一。对3个采样点的发病率数据进行比较，以确定趋势。假设：在10年的抽样期内，人工耳蜗制造工艺和手术技术的改进，相对于那些复杂、多因素或特发性起源的人工耳蜗，将导致由主要装置故障或手术因素引起的人工耳蜗不良事件的比例下降。结果和结论：统计分析显示，与具有明确定义的潜在器械相关或医学原因的CI不良事件相比，具有多种或未知原因的CI不良事件的比例随着时间的推移显着增加，特别是逐渐特发性性能下降的病例。结论：研究结果表明，迫切需要开展进一步的研究，以调查特发性和渐进性CI不良事件的原因，以继续CI结局的总体改善。
Objectives: To review worldwide data on cochlear implant adverse events, test for significant trends over a 10-year period and discuss possible reasons behind such trends. To evaluate the suitability of the Manufacturer and User Facility Device Experience (MAUDE) database for analysis of trends in cochlear implant adverse events.Study Design: Retrospective analysis of cochlear implant adverse events reported to the U.S. Food and Drug Administration (FDA) as recorded on the MAUDE database. Data for each adverse event reported in the years 2000 (n = 237), 2005 (n = 1089), and 2010 (n = 2543) were evaluated and assigned to one of 14 categories according to report content. Incidence data were compared across the 3 sampling points to determine trends.Hypothesis: Improvements in cochlear implant manufacturing processes and surgical techniques would result in a decrease in the proportion of CI adverse events because of primary device failure or surgical factors, relative to those with complex, multifactorial or idiopathic origins, over the 10 year sampling period.Results and Conclusion: Statistical analyses showed a significant increase over time in the proportion of CI adverse events that had multiple or unknown causes, particularly cases of gradual idiopathic loss of performance, as compared with those with a clearly defined underlying device-related or medical cause.Conclusions: Findings suggest that there is an urgent need to undertake further research to investigate causes for idiopathic and gradual CI adverse events to continue the overall improvement in CI outcomes.