人工耳蜗植入体的可靠性及检测方法
陈慧琴;魏红芳;谭治平;银力;周道民;
1:浙江省神经电子与脑机接口技术重点实验室
摘要关键词基金项目(Foundation):作者参考文献1 American National Standard.ANSI/AAMI CI86:2017 Cochlear implant systems:requirements for safety,functional verification,labeling and reliability reporting [S].2017.https://webstore.ansi.org/standards/AAMI/ANSIAAMICI862017.
2 李良巧.可靠性工程师手册[M].北京：中国人民出版社，2012.11-12.
3 International Standard.ISO 14708-7:2019 Implants for surgery-active implantable medical devices-part 7:particular requirements for cochlear and auditory brainstem implant systems [S].2019.https://www.iso.org/standard/67701.html.
4 Battmer RD,O Donoghue GM,Lenarz T.A multicenter study of device failure in European cochlear implant centers[J].Ear & Hearing,2007,28(2 Supple):95-99.
5 Venail F,Sicard M,Pierre J,et al.Reliability and complications of 500 consecutive cochlear implantations[J].Arch Otolaryngol Head Neck Surg,2008,134(12):1276-1281.
6 Cullen RD,Fayad JN,Luxford WM,et al.Revision cochlear implant surgery in children[J].Otology & Neurotology,2008,29(2):214-220.
7 Wang JT,Wang AY,Psarros C,et al.Rates of revision and device failure in cochlear implant surgery:a 30-year experience[J].Laryngoscope,2014,124(10):2393-2399.
8 宋跃帅，王振晓，谢静，等.人工耳蜗再植入的病因及治疗[J].中国耳鼻咽喉头颈外科，2018,25(11):588-590.
9 Kim SY,Min BK,Chung WH,et al.Evaluating reasons for revision surgery and device failure rates in patients who underwent cochlear implantation surgery[J].JAMA Otolaryngology Head and Neck Surgery,2020,146(5):414-420.
10 Balkany TJ,Hodges AV,Buchman CA,et al.Cochlear implant soft failures consensus development conference statement[J].Otology & Neurotology,2005,26(4):815-818.
11 Zhou D,Greenbaum E.Implantable neural prostheses 2[M].New York:Springer,2010.27-61.
12 US FDA.Recalls,market withdrawals,& safety alerts.https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
13 付丽，陈甜甜，张克，等.人工耳蜗植入体刺激器外壳气密性检测方法[J].医疗装备，2020,33(5):46-48.
14 Gubbels SP,Mcmenomey SO.Safety study of the Cochlear Nucleus 24 device with internal magnet in the 1,5 Tesla magnetic resonance imaging scanner[J].Laryngoscope,2010,116(6):865-871.
15 Zhou DD,Greenberg R.Electrochemistry in neural stimulation by biomedical implants[J].Electrochemistry,2011,17(3):262-269.
16 Shannon RV.A model of safe levels for electrical stimulation[J].IEEE Transactions on Biomedical Engineering,1992,39(4):424-426.
17 Rebscher S,Zhou DD,Zeng FG.Development and clinical introduction of the Nurotron cochlear implant electrode array[J].Journal of International Advanced Otology,2018,14(3):392-400.