Briggs Robert J S
Department of Otolaryngology, University of Melbourne, East Melbourne, Australia.
Cochlear Implants Int. 2011 May;12 Suppl 1:S22-5. doi: 10.1179/146701011X13001035752291.
It has been over 50 years since Djourno and Eyries first attempted electric stimulation in a patient with deafness. Over this time, the Cochlear Implant (CI) has become not only remarkably successful, but increasingly complex. Although the basic components of the system still comprise an implanted receiver stimulator and electrode, externally worn speech processor, microphone, control system, and power source, there are now several alternative designs of these components with different attributes that can be variably combined to meet the needs of specific patient groups. Development by the manufacturers has been driven both by these various patient needs, and also by the desire to achieve technological superiority, or at least differentiation, ultimately in pursuit of market share. Assessment of benefit is the responsibility of clinicians. It is incumbent on both industry and clinicians to ensure appropriate, safe, and affordable introduction of new technology. For example, experience with the totally implanted cochlear implant (TIKI) has demonstrated that quality of hearing is the over-riding consideration for CI users. To date, improved hearing outcomes have been achieved by improvements in: speech processing strategies; microphone technology; pre-processing strategies; electrode placement; bilateral implantation; use of a hearing aid in the opposite ear (bimodal stimulation); and the combination of electric and acoustic stimulation in the same ear. The resulting expansion of CI candidacy, with more residual hearing, further improves the outcomes achieved. Largely facilitated by advances in electronic capability and computerization, it can be expected that these improvements will continue. However, marked variability of results still occurs and we cannot assure any individual patient of their outcome. Realistic goals for implementation of new technology include: improved hearing in noise and music perception; effective invisible hearing (no external apparatus); automated fitting; and reduction in outcome variability. This paper provides examples of relevant potential future technologies that can be applied to reach these goals. In the quest for better outcomes, future technology must deliver improved reliability and usability for both clinicians and recipients that does not compromise safety and is affordable. One of the challenges related to the introduction of new technologies is the 'classification' of CI systems and the framework under which sufficient change and increased benefit can be demonstrated to establish a claim of 'new generation CI' and hence increased reimbursement from third-party payers. Significant improvements in hearing outcomes and quality of life associated with CI design changes are difficult to measure, particularly when there is such dramatic benefit from the intervention of cochlear implantation from the individual's perspective. Manufacturers and clinicians need to be objective and undertake appropriate safety studies and long-term and multi-centre clinical trials to ensure that the introduction of new technology is both safe and effective and supported by health systems worldwide.
自乔尔诺(Djourno)和埃里斯(Eyries)首次尝试对一名耳聋患者进行电刺激以来,已经过去了50多年。在这段时间里,人工耳蜗(CI)不仅取得了显著成功,而且越来越复杂。尽管该系统的基本组件仍然包括植入式接收器刺激器和电极、外置语音处理器、麦克风、控制系统和电源,但现在这些组件有几种不同的设计,具有不同的特性,可以进行不同的组合以满足特定患者群体的需求。制造商的发展既受到这些不同患者需求的推动,也受到追求技术优势(或至少是差异化)的愿望的驱动,最终是为了追求市场份额。评估益处是临床医生的责任。确保新技术以适当、安全且经济实惠的方式引入,这是行业和临床医生共同的责任。例如,全植入式人工耳蜗(TIKI)的经验表明,听力质量是人工耳蜗使用者首要考虑的因素。迄今为止,通过以下方面的改进实现了听力结果的改善:语音处理策略;麦克风技术;预处理策略;电极放置;双侧植入;对侧耳使用助听器(双耳刺激);以及同一耳中电刺激和声学刺激的结合。由此导致人工耳蜗适用范围扩大,残余听力更多,进一步改善了所取得的结果。在很大程度上得益于电子能力和计算机化的进步,可以预期这些改进将持续下去。然而,结果的显著差异仍然存在,我们无法向任何个体患者保证其结果。实施新技术的现实目标包括:改善噪声环境下的听力和音乐感知;实现有效的隐形听力(无外部设备);自动适配;以及减少结果差异。本文提供了一些相关潜在未来技术的示例,这些技术可用于实现这些目标。在追求更好结果的过程中,未来技术必须为临床医生和接受者提供更高的可靠性和可用性,同时不损害安全性且价格合理。与引入新技术相关的挑战之一是人工耳蜗系统的“分类”以及框架,在该框架下能够证明有足够的改变和更大的益处,从而确立“新一代人工耳蜗”的主张,进而从第三方支付者那里获得更多报销。与人工耳蜗设计变更相关的听力结果和生活质量的显著改善难以衡量,特别是当从个体角度看人工耳蜗植入干预带来如此巨大益处时。制造商和临床医生需要保持客观,进行适当的安全性研究以及长期和多中心临床试验,以确保新技术的引入既安全又有效,并得到全球卫生系统的支持。