Clinical experience with the Nurotron™ cochlear implant in a Spanish-speaking postlingual population: Clinical safety and audiological results

Leonardo Elías Ordóñez Ordóñez , Esther Sofía Angulo Martínez , Silvia Carolina Vanegas , Silvia Raquel Rodríguez Montoya
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Abstract

Objective

to assess clinical safety and postoperative audiological outcomes in postlingual deafness Spanish speaking patients, who underwent surgery with Nurotron™ cochlear implant.

Material and methods

Retrospective descriptive case series study. We performed follow-up of complications and audiological measurements before and after cochlear implantation. Patients with bilateral severe to profound sensorineural hearing loss or patients with unilateral deafness with/without tinnitus were included. Repeated-measures within-subjects for assess pure tone thresholds and speech performance (bilingual test) with a detailed monitoring to establish security or adverse effects were performed. Analysis of variance tests, repetitive measures, were used for statistical analysis.

Results

31 patients were included, 17 (54.8%) men and 14 (45.2%) women. Mean age at the time of surgery was 49.82 ± 18.8 years. The mean follow-up of the group was 31.56 ± 9.57 months (minimum = 19.6 months and maximum = 52.50 months). As major complication one patient (3.23%) had a hard failure that required removal and re-implantation. 25.8% of the patients presented minor complications, the most frequent being vertigo/unsteadiness in 22.6%.

The mean of language discrimination (free field at 65 dB SPL) was 62.19% ± 16.66; being 69.82% ± 7.35 in the group of severe to profound bilateral sensorineural hearing loss. A statistically significant reduction was observed in patients with tinnitus, assessed using the visual analogue scale, preoperative = 7.2 ± 1,6 vs postoperative (18months postoperative) = 1.7 ± 1.3 (p < .001).

Conclusions

The Nurotron™ cochlear implant shows satisfactory audiological results, in accordance with what has been reported in the literature. Minor complications were similar to previous studies, but the percentage of hard failure should continue to be observed, which was higher than other reports with comparable follow-up.

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Nurotron™ 人工耳蜗在西班牙语后语言人群中的临床经验:临床安全性和听力结果。
目的:对接受 Nurotron™ 人工耳蜗手术的西班牙语语后聋患者的临床安全性和术后听力结果进行评估:回顾性描述性病例系列研究。我们对人工耳蜗植入前后的并发症和听力测量结果进行了随访。研究对象包括双侧重度至极重度感音神经性听力损失患者或单侧耳聋伴/不伴有耳鸣的患者。对纯音阈值和语言表达能力(双语测试)进行了受试者内重复测量,并进行了详细监测,以确定安全性或不良影响。统计分析采用方差分析、重复测量:共纳入 31 名患者,其中男性 17 名(54.8%),女性 14 名(45.2%)。手术时的平均年龄为(49.82 ± 18.8)岁。平均随访时间为 31.56 ± 9.57 个月(最短 = 19.6 个月,最长 = 52.50 个月)。作为主要并发症,一名患者(3.23%)出现了硬性故障,需要移除并重新植入。25.8%的患者出现了轻微并发症,其中最常见的是眩晕/不稳定,占 22.6%。语言辨别力(65 dB SPL 时的自由场)的平均值为 62.19%±16.66;重度至极重度双侧感音神经性听力损失组为 69.82%±7.35。使用视觉模拟量表进行评估后发现,耳鸣患者的术前耳鸣率(7.2±1.6)与术后(术后 18 个月)耳鸣率(1.7±1.3)之间的差异有统计学意义(P 结论):Nurotron™ 人工耳蜗的听力效果令人满意,与文献报道一致。轻微并发症与之前的研究相似,但应继续观察硬性故障的比例,该比例高于其他具有可比性随访的报告。
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