Briggs Robert J S, Eder Helmut C, Seligman Peter M, Cowan Robert S C, Plant Kerrie L, Dalton James, Money David K, Patrick James F
Department of Otolaryngology, University of Melbourne, East Melbourne, Victoria, Australia.
Otol Neurotol. 2008 Feb;29(2):114-9. doi: 10.1097/MAO.0b013e31814b242f.
To evaluate the effectiveness and issues associated with a research totally implantable cochlear implant (TIKI).
Limited patient trial.
Tertiary referral center.
Three adult human subjects with severe-to-profound sensorineural hearing loss.
Subjects were implanted with a research TIKI developed by Cochlear Limited and the Co-operative Research Centre for Cochlear Implant and Hearing Aid Innovation. The TIKI has a lithium ion rechargeable battery, a package-mounted internal microphone, and sound-processing electronics that enable the use of "invisible hearing" without the use of an external device. The TIKI also functions with an external ESPrit 3G sound processor as a conventional cochlear implant. The standard surgical technique was modified to accommodate the larger device package. Postoperatively, subjects used TIKI in both invisible hearing and the conventional ESPrit 3G modes.
Device use was recorded in both invisible hearing and ESPrit 3G listening modes. Performance of the internal battery and microphone was assessed over time. Psychophysical MAP data were collected, and speech perception was measured at 1, 3, 6, and 12 months postoperatively in both listening modes.
There were no surgical or postoperative complications. All subjects use both invisible hearing and conventional ESPrit 3G modes. Speech perception outcomes for all patients showed improvement from preoperative scores. As a consequence of the reduced sensitivity of the implanted microphone, speech perception results using the invisible hearing mode were significantly lower than the ESPrit 3G mode. Subjects reported some body noise interference that limited use of the invisible hearing mode; however, all continue to use the invisible hearing mode on a limited daily basis. The rechargeable battery functioned well, with a cycle time indicating the low-power implant design is effective and will deliver long battery life.
This study demonstrates that the challenges in developing a safe and effective TIKI can be overcome. Three subjects implanted with the research TIKI all reported benefit from routine use. For each subject, hearing outcomes using invisible hearing mode were not as good as when using the external ESPrit 3G sound processor in the conventional mode.
评估一种研究性全植入式人工耳蜗（TIKI）的有效性及相关问题。
有限患者试验。
三级转诊中心。
三名重度至极重度感音神经性听力损失的成年受试者。
为受试者植入由科利耳有限公司及人工耳蜗与助听器创新合作研究中心研发的研究性TIKI。TIKI有一个锂离子可充电电池、一个封装在组件内的内置麦克风以及声音处理电子设备，可实现无需外部设备的“隐形听力”功能。TIKI也可与外部ESPrit 3G声音处理器配合，作为传统人工耳蜗使用。标准手术技术进行了改进以适应更大的设备组件。术后，受试者在隐形听力和传统ESPrit 3G模式下使用TIKI。
记录隐形听力和ESPrit 3G聆听模式下的设备使用情况。随时间评估内置电池和麦克风的性能。收集心理物理学MAP数据，并在术后1、3、6和12个月测量两种聆听模式下的言语感知。
无手术或术后并发症。所有受试者均使用隐形听力和传统ESPrit 3G模式。所有患者的言语感知结果较术前评分均有改善。由于植入麦克风的灵敏度降低，隐形听力模式下的言语感知结果显著低于ESPrit 3G模式。受试者报告存在一些身体噪音干扰，限制了隐形听力模式的使用；然而，所有人仍继续在有限的日常时间内使用隐形听力模式。可充电电池功能良好，循环时间表明低功耗植入设计有效且电池续航时间长。
本研究表明，开发安全有效的TIKI所面临的挑战是可以克服的。三名植入研究性TIKI的受试者均报告从常规使用中获益。对于每名受试者，隐形听力模式下的听力结果不如在传统模式下使用外部ESPrit 3G声音处理器时好。
