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机器人辅助或手动耳蜗植入的阻抗与功能结果:一项对比研究

Impedance and Functional Outcomes in Robotic-Assisted or Manual Cochlear Implantation: A Comparative Study.

作者信息

Gersdorff Guillaume, Peigneux Nicolas, Duran Unal, Camby Severine, Lefebvre Philippe P

机构信息

Department of Oto-Rhino-Laryngology, Head and Neck Surgery, Liège University, CHU de Liège, Liège, Belgium.

Department of Diagnostic Radiology, Liège University, CHU de Liège, Liège, Belgium.

出版信息

Audiol Neurootol. 2025;30(1):80-88. doi: 10.1159/000540577. Epub 2024 Aug 23.

Abstract

INTRODUCTION

Preservation of residual hearing, mainly the low frequencies, is the current main objective of cochlear implantation. New electrode arrays and the development of minimally invasive surgery have allowed electroacoustic stimulation. Over the past several years, robotic-assisted cochlear implant surgery aimed to improve the insertion process while respecting inner ear structures. However, the introduction of a foreign body inside the cochlea can lead to the development of fibrous tissue around the electrode array, or even induce osteogenesis. These histological changes disrupt the parameters of the cochlear implant, resulting in elevated impedance. In addition, long-term auditory performance can be affected, with a deterioration in word comprehension. We evaluated the potential impact of RobOtol® on impedance changes over time, leading to potentially positive functional outcomes.

METHODS

Cochlear implant surgery with a round window approach was performed under general anesthesia. Fifteen Med-El Flex24 electrode arrays were inserted manually and 24 using RobOtol®. All subjects underwent pure-tone audiometry tests before the surgery and at regular intervals up to 1 year after the surgery. Based on the pure-tone average at the low frequencies from 250 to 1,000 Hz, we divided the patients according to the degree of auditory preservation (full preservation ≤15 dB, partial preservation 15 dB-30 dB, significant loss >30 dB). These different groups were compared in terms of impedance changes and auditory performance, specifically word recognition score.

RESULTS

We found proportionally fewer patients who experienced significant low-frequency hearing loss after robotic insertion (53.33% in the manual group compared to 41.67% in the robot-assisted insertion group). Impedance changes at the apex of the electrode array, especially at the first electrode (p = 0.04), after robotic surgery, with less overall variability, a continuous decreasing trend without secondary elevation, and lower values in cases of complete residual hearing preservation (for the three first electrodes: p = 0.017, p = 0.04, p = 0.045). The speech intelligibility amelioration over time showed favorable evolution in patients with complete residual hearing preservation regardless of the insertion method. However, in the absence of auditory preservation, the positive evolution continued more than 6 months after robotic surgery but stagnated after manual insertion (difference at 1 year, p = 0.038; median auditory capacity index 83% vs. 57%).

CONCLUSION

Atraumatic electrode array insertion with consistent, slow speed and the assistance of RobOtol® minimizes disturbances in the delicate neurosensory structures of the inner ear and leads to better auditory performance.

摘要

引言

保留残余听力,主要是低频听力,是目前人工耳蜗植入的主要目标。新型电极阵列和微创手术的发展使得电声刺激成为可能。在过去几年中,机器人辅助人工耳蜗植入手术旨在在尊重内耳结构的同时改善电极插入过程。然而,将异物引入耳蜗内部可能会导致电极阵列周围纤维组织的形成,甚至诱导骨生成。这些组织学变化会破坏人工耳蜗的参数,导致阻抗升高。此外,长期听觉表现可能会受到影响,单词理解能力下降。我们评估了RobOtol®对随时间变化的阻抗的潜在影响,这可能会带来积极的功能结果。

方法

在全身麻醉下采用圆窗入路进行人工耳蜗植入手术。手动插入15个Med-El Flex24电极阵列,使用RobOtol®插入24个。所有受试者在手术前以及术后定期进行纯音听力测试,直至术后1年。根据250至1000Hz低频段的纯音平均值,我们根据听觉保留程度(完全保留≤15dB,部分保留15dB - 30dB,显著损失>30dB)对患者进行分组。比较这些不同组在阻抗变化和听觉表现方面的差异,特别是单词识别得分。

结果

我们发现机器人辅助插入后出现显著低频听力损失的患者比例相对较少(手动组为53.33%,机器人辅助插入组为41.67%)。机器人手术后,电极阵列顶端尤其是第一个电极处的阻抗变化(p = 0.04),总体变异性较小,呈持续下降趋势且无二次升高,在完全保留残余听力的情况下值更低(对于前三个电极:p = 0.017,p = 0.04,p = 0.045)。无论插入方法如何,随着时间推移,完全保留残余听力的患者语音清晰度改善情况良好。然而,在没有听觉保留的情况下,机器人手术后积极的改善持续超过6个月,但手动插入后停滞(1年时差异,p = 0.038;中位听觉能力指数83%对57%)。

结论

在RobOtol®的辅助下,以一致、缓慢的速度进行无创电极阵列插入可最大程度减少对内耳精细神经感觉结构的干扰,并带来更好的听觉表现。

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