Barbara Maurizio, Volpini Luigi, Filippi Chiara, Atturo Francesca, Monini Simonetta
a Nesmos Department, ENT Unit, Medicine and Psychology , Sapienza University , Rome , Italy.
Acta Otolaryngol. 2018 Jan;138(1):31-35. doi: 10.1080/00016489.2017.1371327. Epub 2017 Aug 30.
The aim of this article is to report on the long-term follow-up of a new semi-implantable middle ear device utilized for restoration of moderate-to-severe sensorineural hearing loss in a first series of subjects.
Three subjects, affected by sensorineural hearing loss, have undergone implantation of Maxum middle ear implant, via a transcanal approach. They all underwent an auditory assessment, paying particular attention on the pre- versus post-operative hearing levels under the unaided, best-fitted hearing aided and implant-aided conditions. The audiometric evaluation has been repeated 3 years after implantation and implemented by questionnaires aiming at the evaluation of the quality of life.
The post-operative hearing threshold and discrimination in quiet appear to be similar or better than those provided by conventional hearing aids, with a concomitant improvement of the subjects' quality of life. The application of the present device showed to be easy and reproducible, with no severe adverse effects recorded at the 3-years follow-up. Mild issues due to the external component were also observed, such as difficulty of keeping it continuously in place due to excess canal sweating in one subject, and a temporary loss of stability due to occurring irregularities of the external coating in another subject.
Long-term, preliminary data reveal that the Maxum device may provide equal or better functional gain and word recognition scores in quiet in patients with moderate-to-severe sensorineural hearing loss, in comparison to optimally fitted hearing aids, with a satisfactory improvement of their quality of life.
本文旨在报告在首批受试者中使用新型半植入式中耳装置恢复中重度感音神经性听力损失的长期随访情况。
三名感音神经性听力损失患者通过经耳道入路植入了Maxum中耳植入物。他们均接受了听觉评估，特别关注在未佩戴、最佳适配助听器和植入辅助条件下的术前与术后听力水平。植入后3年重复进行听力测定评估，并通过问卷调查对生活质量进行评估。
术后安静环境下的听力阈值和辨别能力似乎与传统助听器相当或更好，同时受试者的生活质量也有所改善。本装置的应用操作简便且可重复，在3年随访中未记录到严重不良反应。也观察到了一些与外部组件相关的轻微问题，例如一名受试者耳道出汗过多导致外部组件难以持续固定在位，另一名受试者外部涂层出现不规则情况导致稳定性暂时丧失。
长期初步数据显示，与最佳适配的助听器相比，Maxum装置在中重度感音神经性听力损失患者中可能在安静环境下提供同等或更好的功能增益和单词识别分数，且能使其生活质量得到令人满意的改善。
