A new semi-implantable middle ear implant for sensorineural hearing loss: three-years follow-up in a pilot patient’s group

Abstract

Objective: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Chinese abstract

目的：本文的目的是报告在第一系列受试者中用于恢复中度至重度感觉神经性听力损失的新型半植入式中耳装置的长期随访。

方法：受感觉神经性听力损失影响的三名受试者通过经耳道法进行了Maxum®中耳植入术。他们都进行了听觉评估, 特别注意到在无辅助、最佳拟合听力辅助和植入辅助条件下的术前和术后听力水平。听力评估在植入后3年再次进行, 旨在评估生活质量。

结果：术后听觉阈值和安静度差异似乎与常规助听器的相似或更好, 受试者生活质量得到提高。本装置的应用显示容易操作并有重复性效果, 3年随访中无严重不良反应的记录。还观察到由于外界原因引起的小问题, 例如由于一个受试者耳道过度出汗而导致装置难于持续保持在一个位置；另一个受试者由于外部涂层发生的不规则性而导致稳定性暂时缺失。

结论：长期初步数据显示, 与最佳安装的助听器相比, Maxum®装置可以为中度至重度感觉神经性听力损失的患者提供相等或更好的功能和词语识别水平的改善, 令人满意地提高他们的生活质量。

Keywords:

• Active middle ear implant
• sensorineural hearing loss
• Maxum
• semi-implantable hearing device

Disclosure statement

No potential conflict of interest was reported by the authors.