目的 观察儿童诺尔康人工耳蜗植入患者术后3年的康复效果,评价该国产人工耳蜗的安全性和有效性.方法 2011年4月至6月植入诺尔康晨星人工耳蜗系统的双侧重度或极重度感音神经性聋患儿60例,植入年龄12 ~71个月,平均(39.6±18.9)个月.所有植入患儿术后3~4周开机,并在开机后3个月、1年、2年和3年定期随访,对人工耳蜗装置的使用情况和工作状态进行跟踪,同时对其听觉康复效果进行评估,并应用SAS 9.13统计软件进行数据分析.结果 60例患儿均手术成功,开机后能坚持每日佩戴使用人工耳蜗,随访期间无与人工耳蜗植入相关的并发症发生,人工耳蜗装置整体工作状态良好.患儿声场言语频率的助听听阈测试,韵母、声母、单音节词和双音节词测试,Ling氏六音测试,婴幼儿有意义听觉整合量表(Infant-Toddler Meaningful Auditory Integration Scale,IT-MAIS)得分均较术前明显提高,并随着人工耳蜗使用时间延长而逐渐改善.植入儿童的语法能力、理解能力、交往能力和表达能力测试结果也随着耳蜗使用时间的延长有明显提高.结论 随着人工耳蜗使用时间的延长,儿童植入者的听觉和语言评估测试结果显著提高,诺尔康晨星人工耳蜗系统具有良好的安全性和有效性.
Objective To observe the long-term safety and performance of Nurotron cochlear implant system.To analyze the auditory and speech rehabilitation characteristic of pediatric deafened patients after cochlear implantation.Methods To analyze 3 years results of pediatric deafened patients with Nurotron(R) VenusTM cochlear implants.From April to June 2011,sixty deaf children received domestic cochlear implant.All subjects were switched on after 3 to 4 weeks of surgery,and were assessed the auditory rehabilitation on 3 months,12 months,24 months and 36 months after switching on.To evaluate the rehabilitation results by Aided Hearing Thresholds,Auditory & Verbal Ability Test and IT-MAIS Questionnaire.Meanwhile,the safety and performance of cochlear implant system were followed-up.Before surgery,all the recipients in this study were 12 to 71 months of age with the average hearing threshold higher than 90 dBHL.Results Sixty cases of deaf children were implanted successfully.All the recipients used their devices every day,and all of their devices worked well.No complication or side effect related to implantation were found.The sound field aided hearing thresholds,vowels,consonants,monosyllabic words and two-syllable words test,as well as Ling's test,and IT-MAIS Questionnaire of all recipients were improved significantly with prolonged use of CI device.The results of grammatical competence,understanding,communication and presentation skills tests also get significantly promotion in 3 years follow up.Conclusions With prolonged use of CI device,the hearing and language tests of children recipients could obtain significantly improvement.The Nurotron(R) VenusTM CI system works safely and effectivelv.