在人工耳蜗植入过程中保持自然听力与改善言语效果有关,然而,超过一半的植入物接受者失去了这种听力。植入过程中耳蜗输出的实时电生理监测,通过使用耳蜗植入物上的电极记录耳蜗电描记术,在预测听力保留方面表现出了希望。耳蜗微音(CM)振幅的突然下降已被证明可以预测更严重的听力损失。这里,我们报道了一项随机临床试验,该试验调查了由这些滴注引发的即时手术干预是否可以挽救残余听力.
一项单盲安慰剂对照的手术干预试验,在耳蜗植入过程中,CM振幅下降了之前最大振幅的至少30%。记录了60例植入了CochlearLtd的薄直形电极的成年人的术中耳蜗电图,一半随机分配到对照组,一半随机分配到介入组。手术干预是以1/2-mm的步长撤回电极以恢复CM振幅。主要结果是植入后3个月的听力保留,根据组或CM结果,语音噪声接收阈值的次要结果,和植入深度。
共招募了60例患者;两组之间的术前测听和言语接收阈值均无显著差异。术后,介入组的听力保留明显更好。绝对差就是这种情况(对照的中位数为30dB,20dB的介入,χ²=6.2,p=.013),以及相对差异(对照组的中位数为66%,31%为介入,χ²=5.9,p=.015)。与CM下降的患者相比,在插入过程中任何时候没有CM下降的患者的语音噪声接收阈值明显更好;但是,那些在初始下降后成功恢复的CM没有显着差异(语音接收分数高于6.9dB噪声的50%所需的中值增益没有下降,回收CM为8.6,和9.8的CM下降,χ²=6.8,p=.032)。对照组和介入组之间的角度插入深度没有显着差异。
这是首次证明,响应术中听力监测的手术干预可以在人工耳蜗植入过程中节省残余听力。
Preservation of natural hearing during cochlear implantation is associated with improved speech outcomes, however more than half of implant recipients lose this hearing. Real-time electrophysiological monitoring of cochlear output during implantation, made possible by recording
electrocochleography using the electrodes on the cochlear implant, has shown promise in predicting hearing preservation. Sudden drops in the amplitude of the cochlear microphonic (CM) have been shown to predict more severe hearing losses. Here, we report on a randomized clinical
trial investigating whether immediate surgical intervention triggered by these drops can save residual hearing.
A single-blinded placebo-controlled
trial of surgical intervention triggered when CM amplitude dropped by at least 30% of a prior maximum amplitude during cochlear implantation. Intraoperative
electrocochleography was recorded in 60 adults implanted with Cochlear Ltd\'s Thin Straight Electrode, half randomly assigned to a control group and half to an interventional group. The surgical intervention was to withdraw the electrode in ½-mm steps to recover CM amplitude. The primary outcome was hearing preservation 3 months following implantation, with secondary outcomes of speech-in-noise reception thresholds by group or CM outcome, and depth of implantation.
Sixty patients were recruited; neither pre-operative audiometry nor speech reception thresholds were significantly different between groups. Post-operatively, hearing preservation was significantly better in the interventional group. This was the case in absolute difference (median of 30 dB for control, 20 dB for interventional, χ² = 6.2, p = .013), as well as for relative difference (medians of 66% for the control, 31% for the interventional, χ² = 5.9, p = .015). Speech-in-noise reception thresholds were significantly better in patients with no CM drop at any point during insertion compared with patients with a CM drop; however, those with successfully recovered CMs after an initial drop were not significantly different (median gain required for speech reception score of 50% above noise of 6.9 dB for no drop, 8.6 for recovered CM, and 9.8 for CM drop, χ² = 6.8, p = .032). Angular insertion depth was not significantly different between control and interventional groups.
This is the first demonstration that surgical intervention in response to intraoperative hearing monitoring can save residual hearing during cochlear implantation.