不同人工耳蜗植入手术术中护理配合

目的 总结3种不同人工耳蜗植入手术术中配合经验.方法 总结2010年5月～2010年12月间,132例患儿进行人工耳蜗植入术的术中配合,其中澳大利亚产品手术91例,奥地利产品38例,美国3例.全部病例均在全麻下进行,均按手术器械的准备流程、不同人工耳蜗手术特点和手术流程进行手术的配合.结果132例患儿人工耳蜗植入手术顺利.3种手术的区别在于:①术中切口有区别:澳大利亚人工耳蜗手术切口为4.0cm、共91例;美国BIONICS 90K为5.0cm,共3例;奥地利为8cm,共38例.②术中磨开植入体骨嵌有区别:澳大利亚为直径1.2cm的圆形骨槽、共91例;美国BIONICS 90K为直径2.0cm圆形骨槽,3例;奥地利为3.0cm×2.6cm半边椭圆形骨槽、共38例.③植入人工耳蜗电极方法不同:澳大利亚K型号为直电极,需要用镊子送入后用专用叉子送入耳蜗内超过17cm9例,CA和Fredom电极为弯电极使用专用镊子送入10～12cm深后继续向内推入超过16cm后边抽出支撑的钛丝82例.奥地利标准电极使用专业叉子和镊子向耳蜗内推入31cm,38例.美国BIONICS 90K使用专业推进器向耳蜗内推进25cm后取出推进器3例.3种人工耳蜗植入手术术中配合时间:澳大利亚人工耳蜗手术91例平均手术时间33分钟,奥地利人工耳蜗植入手术38例平均手术配合时间52分钟,美国BIONICS 90K人工耳蜗3例术中配合时间平均42分钟.结果 132例人工耳蜗手术,术后均无手术区周围损伤,无面瘫及鼓索神经损伤等并发症发生.结论 人工耳蜗植入手术中,上台护士进行手术配合,了解人工耳蜗植入手术流程、清楚不同人工耳蜗植入手术特点和使用手术器械的特点,密切配合术者手术,达到了安全、快速、高质量,避免了术后并发症的发生.     

人工耳蜗植入手术并发症及临床分析

目的 探讨人工耳蜗植入手术并发症的预防及处置.方法 回顾分析2000年12月至2010年8月在我科由单一术者完成的416例人工耳蜗植入手术,发生并发症29例(29/416),占7%,随访时间1个月～10年,并对其原因进行分析,提出预防及处置的措施.结果 29例并发症中,按轻重程度分为:轻度并发症23例,占5.5%,包括术后皮下血肿13例,急性中耳炎2例,术后迟发性切口感染2例,术后迟发性面瘫1例,面肌抽搐1例,术后重度眩晕4例;重度并发症6例,占1.5%,包括脑脊液漏2例、切口感染致植入体外露1例、鼓膜穿孔致电极外露1例、耳蜗骨化至电极未能全部植入1例,磁铁移位1例.无电极耳蜗内扭曲、未植入耳蜗、植入体移位及脑膜炎、永久性面瘫发生.轻度并发症经处置后均痊愈,脑脊液漏经二次手术修补痊愈.电极、植入体外露2例病人,均取出植入体,行对侧耳蜗植入.1例磁铁移位经二次手术予以复位.结论 如何降低人工耳蜗植入手术严重并发症的发生,仍是人工耳蜗植入亟待解决的问题.     

小切口及“T”形肌骨膜瓣在人工耳蜗植入手术中的应用

目的 探讨小切口及“T”形肌骨膜瓣在人工耳蜗植入术中的应用及效果。方法 回顾性分析56例(57耳)就治于大理白族自治州人民医院的重度、极重度感音神经性聋患者，采用耳后皮肤小切口并制作“T”形肌骨膜瓣完成人工耳蜗植入手术，术后记录切口长度、操作时间及术后愈合情况。结果 平均切口长度为(3.5±0.5)cm；平均操作时间为(95±10)min。术后1耳出现切口感染植入体排除，其余患者愈合良好，未出现皮瓣相关并发症。结论 小切口、“T”形肌骨膜瓣应用于电子耳蜗植入手术，不增加手术操作时间，且具有较好的手术视野及较低的皮瓣并发症。     

17例人工耳蜗再植入原因分析

目的总结17例人工耳蜗患者耳蜗再植入的原因，探讨降低耳蜗再植入风险的方法，提高患者手术治疗满意度及术后听力言语康复水平。方法回顾性分析2012年11月—2018年7月解放军总医院海南医院17例采用面隐窝入路圆窗再植入人工耳蜗患者的临床资料,分析其再植入原因。结果17例患者均顺利完成耳蜗再植入手术,再植入术后随访观察患者满意度高，人工耳蜗助听听阈大幅改善，言语分辨能力明显提高，患者听力言语康复效果提升。17例人工耳蜗再植入原因分别为:植入体故障6例；植入体不工作2例；植入体受撞击后损坏2例；植入体接收刺激器移位1例; 植入体接收刺激器部位破裂1例；皮瓣感染3例，其中1例为右侧感染后原植入体同侧再植入，皮瓣感染切口无法愈合后右侧植入体取出后行左侧人工耳蜗植入；电极未完全植入1例；应患者要求取出旧植入体同侧再植入新型植入体1例。结论人工耳蜗再植入原因复杂多样,选择合适材料的植入体、避免剧烈撞击、执行严格的无菌操作以及进行准确的人工耳蜗植入术前评估是避免人工耳蜗再植入的关键。     

259例人工耳蜗植入患者的并发症分析及处理

目的分析259例人工耳蜗植入(cochlear implantation,CI)患者的并发症,探讨并发症产生的原因、处理方法和预后。方法对1997年3月～2006年12月在我科接受人工耳蜗植入的259例患者的并发症及其处理和预后情况进行回顾性分析。结果259例人工耳蜗植入患者平均年龄8.4岁,最小11个月,最大52岁。随访时间平均2.9年。有4例患者发生严重的手术并发症(1例鼓膜穿孔行二期修补术、2例面神经麻痹行面神经减压术、1例脑脊液耳漏合并脑膜炎)。有39例患者出现轻度手术并发症,包括鼓膜穿孔、血肿、切口感染、面神经部分暴露等,经保守治疗或术中简单处理均得到有效控制。与人工耳蜗装置相关的并发症10例(3例人工耳蜗电极未植入或仅部分植入耳蜗内、1例术后电极脱出、5例人工耳蜗装置故障、1例耳蜗内植入后无反应)。所有手术并发症经过保守治疗或手术干预,预后良好。10例人工耳蜗装置故障经调整或再植入后,9例得到圆满解决,1例植入体取出。结论人工耳蜗植入是相对安全的手术。大部分手术并发症为轻度并发症,通过保守治疗或小的手术干预预后良好。人工耳蜗植入病例的选择要注意适应症。     

直电极与弯电极序列人工耳蜗植入深度的比较

目的测量比较Nucleus CI 24M直电极序列和CI24 Contour弯电极序列两种型号植入体的电极植入深度。方法对41例CI 24M和8例CI 24 Contour植入者,术后拍摄耳蜗位X线平片。应用图像处理技术,比照耳蜗螺旋模板,建立电极序列的极坐标图形,测量第22号电极与耳蜗开窗处的极坐标角度,两者之差代表了电极序列的植入深度。以t检验比较两种型号植入体的植入深度状况。结果 无内耳畸形、手术条件相当的情况下,CI 24 Contour植入体的平均插入角度为413°,CI 24M植入体的平均插入角度为316°,P=0.0001。结论CI 24 Contour植入体的植入深度明显深于CI 24M。前者更有利于医师进行植入。     

多导人工耳蜗植入后电极阻抗的初步研究

目的研究多导人工耳蜗植入后电极阻抗变化的特点,对比直电极和弯电极的阻抗差异,为人工耳蜗植入术后的调试提供参考。方法在Nucleus多导人工耳蜗编程调试界面上,应用R126V1.3和NRTV3.0软件,测试11例语前聋儿童在不同时期的阻抗值,并进行分析比较。结果CI24M和CI24Rcontour两种植入体阻抗随时间变化的基本规律是:术中较低,开机时最高,以后随时间推移逐渐降低。CI24Rcontour阻抗高于CI24M。结论人工耳蜗植入体阻抗开机后随时间推移而逐渐降低,新型CI24Rcontour植入体与CI24M相比,其阻抗值在术中至开机后3周内明显要高。     

人工耳蜗再植入病例分析

目的 报告人工耳蜗再植入的常见原因、手术方法及再植入术后患者听力语言康复情况.方法 2007年5月～2010年11月北京友谊医院采用面隐窝进路为23例患者行人工耳蜗再植入,分析其再植入原因及手术方法.结果 23例患者均顺利完成人工耳蜗再植入,再植入术后患者听力言语康复效果满意或正在康复机构接受康复.再次植入的原因分别为:电极植入下鼓室1例;植入体部分破碎1例;电极部分脱出1例;电极从外耳道后壁穿出1例,磁铁移位1例;耳蜗底转骨化致植入失败1例;皮瓣或切口感染4例;耳蜗植入体故障7例;原因不明者3例;电极阻抗无限大2例;左侧耳蜗植入后无反应再植入右侧1例.结论 人工耳蜗再植入的原因多样且较复杂,再植入手术需要注意蜗内纤维化和骨化导致电极植入困难的问题.术前准确评估及患者术后避免头部剧烈碰撞是避免人工耳蜗再植入的关键.     

23例儿童再次人工耳蜗植入手术的临床分析

目的分析23例人工耳蜗植入患儿再植入的原因、处理方法及预后。方法回顾性分析2013年9月—2019年6月行人工耳蜗再植入术患者的临床资料,分析再植入的原因、处理方法及预后。结果人工耳蜗植入后造成再植入的原因：外伤1例,手术固定电极不良1例,术区感染5例,排除言语处理器、手术植入及患者自身原因的助听效果差2例,不明原因植入体故障14例。5例感染患者均为一期行人工耳蜗取出,感染控制后行二期人工耳蜗手术,均为单耳再植入,2例同侧植入,3例对侧植入。23例患者首次均为右耳单侧植入,再次植入时2例患者行双侧人工耳蜗植入,3例患者改为对侧再次植入。再植入术后随访1个月至5年10个月,1例患者术中出现井喷,术后眩晕,3d后缓解;1例患者出现头皮下血肿,术后2周内自行吸收。所有患者术后人工耳蜗听声效果正常。结论人工耳蜗再植入的原因有外伤、手术原因、感染、助听效果差、植入体故障,其中植入体故障和感染是儿童人工耳蜗再次植入的主要原因。再植入手术不影响人工耳蜗的效果,并发症发生率较初次手术无明显提高。为了减少人工耳蜗再植入,提倡精准的微创人工耳蜗植入预防并发症发生,同时加强对患者家长的教育,减少外伤等造成的人工耳蜗故障。     

1068例人工耳蜗植入临床经验的总结

目的通过对10年共1068例人工耳蜗植入手术的总结,为深入开展人工耳蜗植入的临床工作提供经验。方法截至2008年2月,对1068例重度以上耳聋患者植入了多导人工耳蜗,其中包括澳大利亚Nucleus678例、奥地利Medel309例、美国AB81例,其中双侧植入2例,Nucleus和Medel各1例。结果①手术成功率：1068例人工耳蜗植入手术均一次成功,手术成功率100％。②手术并发症：术中面神经电钻灼伤2例,术后1～3个月完全恢复;术后伤口水肿和血肿自行恢复15例。③术后问题：术后1个月出现分泌性中耳炎鼓膜穿孔治疗5个月痊愈1例,肥胖体形线圈固定困难3例,术后耳鸣加重5例,术后伤口感染植入体裸露进行转移肌瓣修复5例,术后外伤植入体损坏二次更换3例,原因不清植入体不工作二次更换2例,期望值达不到患者要求取出2例。④术后效果：声场测听〈45dB、汉语言语识别率〉70％共758例,占71％;声场测听〉45dB、汉语言语识别率〈70％共310例,占29％。结论①1068例人工耳蜗植入术后信息反馈显示：本组人工耳蜗植入手术的成功率达到100％,与国内外平均水平相比有显著的优势。②手术并发症较少而且未发生严重并发症,但是麻醉的风险仍不能忽视,尤其是气道痉挛问题。③术后听觉言语康复问题较多,主要是一些患者术后的听觉言语康复效果差而在术前无法进行准确评估。④目前一些特殊的人工耳蜗植入患者,如耳蜗内听道畸形、听神经病、脑瘫、自闭症、弱智、年龄较大术前昕觉言语基础较差者等,术后听觉言语康复效果不佳。     

Long-term functional outcomes and academic-occupational status in implanted children after 10 to 14 years of cochlear implant use.

OBJECTIVES: To assess a group of consecutively implanted children over 10 years after implantation with regard to implant device use and function, speech perception, and speech intelligibility outcomes; and to document current academic or occupational status. STUDY DESIGN: A prospective longitudinal study assessing device function, device use, speech perception, speech intelligibility, and academic/occupational status of implanted deaf children. SETTING: Pediatric tertiary referral center for cochlear implantation. METHODS: The auditory performance and speech intelligibility development of 30 profoundly deaf children were rated before cochlear implantation and at 5 and 10 years after implantation using the Categories of Auditory Performance and the Speech Intelligibility Rating. The academic and/or occupational status of the participants after 10 years of implant experience was documented. All children received a Nucleus multichannel cochlear implant between the ages of 2.5 and 11 years (mean age at implantation, 5.2 yr). Implant experience ranged from 10 to 14 years of use. RESULTS: After 10 years of implant experience, 26 subjects (87%) reported that they always wore their device; 2 subjects (7%), frequently; and 1 subject (3%), occasionally. Only one child had discontinued use of his device. After 10 years of implant use, 26 (87%) of the children understood a conversation without lip reading and 18 (60%) used the telephone with a familiar speaker. Ten years after implantation, 23 (77%) of the subjects used speech intelligible to an average listener or a listener with little experience of a deaf person's speech. One-third to one-half of the implanted children continued to demonstrate improvements at 5 to 10 years of implant use. Of the 30 implanted children, 8 (26.7%) experienced nine device failures. The length of time from identification of the first faulty electrode to reimplant surgery ranged from 2 weeks to 5.5 years, as several failures were gradual or intermittent. However, all children were successfully reimplanted. At the end of the study (10-14 yr after implantation), 19 subjects were in secondary school for children aged 11 to 16 years: 6 were in mainstream schools, 7 were in specialist hearing-impaired units attached to a mainstream secondary school, and 6 were in schools for the deaf. Of the remaining 11 subjects, 4 were in college studying vocational subjects, 2 were in a university studying for a bachelor's degree, 3 were working full-time, 1 was working and going to a university part-time, and 1 was a full-time mother of two young children. CONCLUSION: All but 1 of the 30 implanted children continue using their devices 10 to 14 years after implantation, showing significant progress in speech perception and production. Device failure was frequent, but successful reimplantation occurred in all cases. One-third to one-half of the implanted children in this study continued to demonstrate improvements at 5 to 10 years of implant use. All children are studying or working and are actively involved in their local communities. The results suggest that cochlear implantation provides long-term communication benefit to profoundly deaf children that does not plateau for some subjects even after reimplantation. This study further indicates that cochlear implant centers need the structure and funding to provide long-term support, counseling, audiologic follow-up, rehabilitation, and device monitoring to implanted children.     

Minimal access surgery for the Symphonix/Med-El Vibrant Soundbridge middle ear hearing implant.

OBJECTIVE: To develop a minimal access approach for implantation of the Vibrant Soundbridge middle ear hearing implant. This approach ideally uses the smallest skin incision possible, minimal or no hair shave, and the least possible amount of tissue and bone manipulation. This will facilitate the acceptability of the procedure to the general community and reduce the flap-related complication rate. The procedure is similar to the minimal access approach described for cochlear implantation. STUDY DESIGN: Eight patients with various degrees of sensorineural hearing loss and one with a mixed hearing loss who met implant criteria for the Vibrant Soundbridge middle ear hearing implant received the device over a 42-month period. The first two patients underwent the traditional implant procedure with postauricular hair shave, postauricular S-shaped incision, and implant receiver suture fixation to the temporal bone. The following seven consecutive patients received a progressively smaller C-shaped postauricular skin incision, no hair shave, retrograde skull drilling for the implant seat, and no implant suture fixation until the technique closely approximated the minimal access cochlear implant procedure. Postoperative performance of the Soundbridge/Vibrant Med-El was evaluated through audiology testing and subjective patient reports. SETTING: Private neurotology clinic and tertiary care teaching hospital. RESULTS: The technique was feasible in all patients. Follow-up for the minimal access group ranged from 3 years to 5 months. There were no complications related to the approach, and all patients were satisfied users of the implant. The lack of hair shave and small incision size was greatly appreciated and warmly endorsed by the patients. CONCLUSION: The Vibrant Soundbridge/Vibrant Med-El can be safely implanted using the minimal access method that has been popularized for cochlear implant surgery. A large incision, extensive hair shave, risk of flap necrosis, and possibility of unsightly scar may deter patients from pursuing the potential benefits of implanted hearing technology. The technique may make the device more accessible to individuals who have concerns regarding cosmetics and potential flap complications.     

Acoustic perception in patients using a cochlear implant before and after adjustment sessions

The aim of the study was comparison of perception of pure tones and speech intelligibility in postlingually deaf patients using a cochlear implant before and after elective adjustment sessions. 10 patients were examined: 5 children (age 8-15.5 years) and 5 adults with cochlear implants NUCLEUS CI22 (6 patients) and NUCLEUS CI24 (4 patients) produced by COCHLEAR (Australia). It was found that between the adjustment sessions all the implanted patients showed deteriorated perception of pure tones throughout all the frequencies and therefore their speech intelligibility worsened. The recommended period between the adjustments is 6 months as acoustic perception degraded with time. However, such observations are not significant in view of insufficient material. Objective assessment of acoustic perception is necessary because subjective sensations are not always true.     

Self-esteem and social well-being of children with cochlear implant compared to normal-hearing children

OBJECTIVE: The purpose of this study was to make a quantitative comparison of parameters of self-esteem and social well-being between children with cochlear implants and normal-hearing children. MATERIAL AND METHODS: Data were obtained from 164 children with cochlear implant (CI) and 2169 normal-hearing children (NH). Parental questionnaires, used in a national survey assessing the self-esteem and well-being of normal-hearing children, were applied to the cochlear implanted group, in order to allow direct comparisons. RESULTS: The children in the CI group rated significantly higher on questions about well-being in kindergarten/school and the CI boys appeared to manage school work better than normal-hearing boys. CI children were significantly more active and bullied other children less than normal-hearing peers, whereas no difference existed as to being bullied by other children. No difference was obtained regarding overall self-esteem or number of friends. The two groups of children scored similarly on being confident, independent, social, not worried and happy. CONCLUSION: Children with cochlear implant score equal to or better than their normal-hearing peers on matters of self-esteem and social well-being.     

Cochlear implantation at under 12 months: report on 10 patients

OBJECTIVES: There is growing evidence that early application of a cochlear implant in children affected by profound congenital hearing loss is of paramount importance for the development of an adequate auditory performance and language skills. For these reasons and as a result of advances in audiologic diagnosis and an enhanced awareness of the safety of cochlear implants, the age of implantation has substantially decreased over recent years. Children aged as little as 12 months are now being implanted in some centers. On the basis of our experience with very young children, we believe that the date of implantation may be further reduced to only 4 to 6 months of age. STUDY DESIGN: Over the period from November 1998 to April 2004, 103 children have been fitted with cochlear implants and 11 with auditory brainstem implants in our department, including 65 children aged below 3 years. The present study focuses on 10 children aged less than 12 months fitted with cochlear implants from November 1998 to December 2003. METHODS: The children's ages ranged from 4 to 11 (mean 9.5) months. Five were males and five females. All received a Nucleus CI 24 M. Postoperative auditory performance, as evaluated at the latest follow-up, was based on the category of auditory performance (CAP). The results obtained in these 10 children were compared with those obtained with cochlear implants in children belonging to older age brackets. The criteria used to assess speech performance were onset of babbling onset and babbling spurt, and the results observed were compared with those of a control group of 10 normally hearing children. RESULTS: Surgery was uneventful, and no immediate or delayed complications were encountered. Auditory performance was seen to increase as function of early age of implantation and length of implant use. All 10 children had a CAP score of 3 within 6 months of cochlear implant activation. The onset of babbling occurred very early (i.e., within 1 to 3 months of activation of the implant in all 10 patients), regardless of age at implantation, whereas the babbling spurt was recorded at times ranging from 3 to 5 months after implant activation. The positive impact of early implantation on babbling was clearly shown by the fact that the earlier the activation of the cochlear implant, the closer the results were to the outcomes of normally hearing children. CONCLUSIONS: We encourage very early implantation to facilitate a series of developmental processes occurring in the critical period of initial language acquisition. The indices we used in the present study (i.e., CAP and babbling) suggest that early cochlear implantation tends to yield normalization of audio-phonologic parameters, which enables us to consider the performance of children implanted very early as being similar to that of their normally hearing peers.     

Will they catch up? The role of age at cochlear implantation in the spoken language development of children with severe to profound hearing loss.

PURPOSE: The authors examined the benefits of younger cochlear implantation, longer cochlear implant use, and greater pre-implant aided hearing to spoken language at 3.5 and 4.5 years of age. METHOD: Language samples were obtained at ages 3.5 and 4.5 years from 76 children who received an implant by their 3rd birthday. Hierarchical linear modeling was used to identify characteristics associated with spoken language outcomes at the 2 test ages. The Preschool Language Scale (I. L. Zimmerman, V. G. Steiner, & R. E. Pond, 1992) was used to compare the participants' skills with those of hearing age-mates at age 4.5 years. RESULTS: Expected language scores increased with younger age at implant and lower pre-implant thresholds, even when compared at the same duration of implant use. Expected Preschool Language Scale scores of the children who received the implant at the youngest ages reached those of hearing age-mates by 4.5 years, but those children implanted after 24 months of age did not catch up with hearing peers. CONCLUSION: Children who received a cochlear implant before a substantial delay in spoken language developed (i.e., between 12 and 16 months) were more likely to achieve age-appropriate spoken language. These results favor cochlear implantation before 24 months of age, especially for children with aided pure-tone average thresholds greater than 65 dB prior to surgery.     

Cochlear implantation in adolescents: Factors influencing compliance

Abstract

Objectives

To quantify rates of non- and partial-use of cochlear implants (CIs) in adolescent patients implanted in adolescence and childhood and identify factors influencing compliance.

Methods

A retrospective case note review undertaken at The Manchester Auditory Implant Centre. Adolescents were defined as young people aged 11–18 years. Individuals implanted in adolescence were defined as Group 1, individuals implanted in childhood under the age of 3 years and currently adolescents were defined as Group 2 and individuals implanted between the age of 3 and11 years and currently adolescents were defined as Group 3. Non-use was defined as not using the CI at all and partial use was defined as consistently using the CI less than full-time, or fluctuating periods of full and less than full-time use.

Results

In Group 1 there was 1 non-user (1.3%) and 11 partial-users (13.9%), with an overall non-compliance rate of 15.2%. In Group 2 there was one non-user (1.9%) and one partial-user (1.9%) with an overall non-compliance rate of 3.8%. In Group 3 there were no non-users and eight partial-users (9%), with an overall non-compliance rate of 9%. The factors influencing compliance differed between groups with the most common factor in Group 1 being a preference for the auditory input gained from the contralateral hearing aid (50%). In Groups 2 and 3 the main factors influencing compliance were behavioural and related to wearing the implant only at school (50 and 75%, respectively).

Conclusions

Patients implanted during adolescence have higher rates of non- and partial-use compared with their adolescent counterparts who have been implanted during childhood. It is important to investigate factors influencing non-compliance so appropriate support may be provided to the patient and their family.     

Systematic review of the literature on the clinical effectiveness of the cochlear implant procedure in paediatric patients

The aim of this systematic review of the literature was to summarize the results of scientific publications on the clinical effectiveness of the cochlear implant (CI) procedure in children. The members of the Working Group first examined existing national and international literature and the principal international guidelines on the procedure. They considered as universally-accepted the usefulness/effectiveness of unilateral cochlear implantation in severely-profoundly deaf children. Accordingly, they focused attention on systematic reviews addressing clinical effectiveness and cost/efficacy of the CI procedure, with particular regard to the most controversial issues for which international consensus is lacking. The following aspects were evaluated: post-CI outcomes linked to precocity of CI; bilateral (simultaneous/ sequential) CI vs. unilateral CI and vs. bimodal stimulation; benefits derived from CI in deaf children with associated disabilities. With regard to the outcomes after implantation linked to precocity of intervention, there are few studies comparing post-CI outcomes in children implanted within the first year of life with those of children implanted in the second year. The selected studies suggest that children implanted within the first year of life present hearing and communicative outcomes that are better than those of children implanted after 12 months of age. Concerning children implanted after the first year of life, all studies confirm an advantage with respect to implant precocity, and many document an advantage in children who received cochlear implants under 18 months of age compared to those implanted at a later stage. With regard to bilateral CI, the studies demonstrate that compared to unilateral CI, bilateral CI offers advantages in terms of hearing in noise, sound localization and during hearing in a silent environment. There is, however, a wide range of variability. The studies also document the advantages after sequential bilateral CI. In these cases, a short interval between interventions, precocity of the first CI and precocity of the second CI are considered positive prognostic factors. In deaf children with associated disabilities, the studies analyzed evidence that the CI procedure is also suitable for children with disabilities associated with deafness, and that even these children may benefit from the procedure, even if these may be slower and inferior to those in children with isolated deafness, especially in terms of high communicative and perceptive skills.     

人工耳蜗植入术的并发症及对症处理

目的　探讨人工耳蜗植入术后并发症产生的原因及处理措施。方法　回顾分析2005年5月～2012年10月在我科接受人工耳蜗植入的721例患者,发生并发症44例。通过分析其原因,提出预防及处理的措施。结果　44例并发症中,轻度并发症34例,包括骨膜下血肿15例;眩晕19例;重度并发症10例,包括面神经损伤2例;感染2例;植入体周围积液2例;耳蜗骨化电极误植入上半规管,后再次植入1例;磁铁移位及磁力消失各1例;植入体移位1例。无电极耳蜗内扭曲,电极移位,永久性面瘫发生等。结论　人工耳蜗植入并发症的预防和处理不容忽视,尤其是要防治术后的严重并发症。     

The reliability of hearing implants: report on the type and incidence of cochlear implant failures

Objectives: This study presents the data collected through a database on the type and incidence of cochlear implant device failures and major complications and quantifies the risk of failures across time based on the Association for the Advancement of Medical Instrumentation (AAMI) CI86:2017 standard.

Methods: Information on reliability of MED-EL cochlear implants was collected from the MED-EL complaint database between 2003 and2013. Explants were categorized and device reliability was calculated according to the AAMI CI86:2017 standard principles.

Results: Data were collected for 11662 devices (5462 children, 6200 adults). The mean duration of follow up was 46.16 months. The total failure rate for all devices and all subjects was 2.41%. Medical related explants (MRE) were significantly worse for children than for adults with the ceramic implants, C40+ (p?=?0.008) and PULSAR (p?=?0.020). Device failure explants (DFE) were significantly worse for children than for adults with all four devices in the study, the C40+ (p?<?0.001), PULSAR (p?<?0.001), SONATA (p?<?0.001), and CONCERTO (p?=?0.023). The mean annual failure rate for all subjects and devices was 0.63% (1.03% for children, 0.28% for adults). The mean annual failure rate was 0.90% for the C40+; 0.57% for the PULSAR; 0.46% for the SONATA; and 0.39% for the CONCERTO.

Conclusions: Compared to adults, children had significantly worse MRE and DFE due to a higher risk of head trauma and more vulnerable skull anatomy. Further, the authors conclude that the AAMI standard will ensure a more comprehensive and transparent evaluation of cochlear implant reliability in the future.