Otorhinolaryngologic Unit, Department of Neurosciences, Mental Health and Sensory Organs, Faculty of Medicine and Psychology, University Hospital Sant'Andrea, Sapienza University, Via di Grottarossa 1035, 00189, Rome, Italy.
Eur Arch Otorhinolaryngol. 2021 Nov;278(11):4289-4294. doi: 10.1007/s00405-020-06565-9. Epub 2021 Jan 1.
To report on failures related to active middle ear implants (AMEI) surgery, within a series of subjects treated at a single Implanting Center.
A retrospective review of 79 cases of implanted AMEI has been performed to report the failure ratio, the causes for the failure and the selected rehabilitative solution. The AMEI included 25 Vibrant Soundbridge (Medel, Innsbruck, Austria), 20 as round window vibroplasty (RW-VSB) for mixed hearing loss, 5 as incus-vibroplasty for sensorineural hearing loss; 7 MET/Carina (Cochlear, Melbourne, Australia), 2 MET for mixed and sensorineural hearing loss, 5 Carina for sensorineural hearing loss; 43 Esteem (EnvoyMedical, St Paul, USA) for sensorineural hearing loss; 3 Maxum (Ototronics, Texas, USA) for sensorineural hearing loss; 1 Codacs (Cochlear, Melbourne, Australia) for severe mixed hearing loss.
The overall complication rate affected 20% of the implanted devices, individually ranging from 6.9 to 100%. Hardware system failures were recorded in all the AMEI, ranging from 10 to 50%. The alternative auditory rehabilitation included replacement of the same system in 2 cases, use of a conventional hearing aid in 3 cases, Cochlear implantation in 4 cases and implantation in the contralateral ear in 2 cases.
The present clinical experience showed that, in spite of the successful functional rate displayed by the majority of the AMEI implantees, complications may occur to a certain percentage of cases and should prompt the professionals to select alternative solutions, starting from the (re)adoption of a conventional hearing aid and ending up to Cochlear implantation.
报告在单一植入中心治疗的一系列患者中，与主动中耳植入物（AMEI）手术相关的失败病例。
对 79 例植入 AMEI 的病例进行回顾性研究，报告失败率、失败原因和选择的康复解决方案。AMEI 包括 25 例 Vibrant Soundbridge（奥地利因斯布鲁克 Medel），20 例用于混合性听力损失的圆窗振动体，5 例用于感音神经性听力损失的砧骨振动体；7 例 MET/Carina（澳大利亚墨尔本 Cochlear），2 例用于混合性和感音神经性听力损失，5 例用于感音神经性听力损失的 Carina；43 例 Esteem（美国圣保罗 EnvoyMedical）用于感音神经性听力损失；3 例 Maxum（美国德克萨斯州 Ototronics）用于感音神经性听力损失；1 例 Codacs（澳大利亚墨尔本 Cochlear）用于重度混合性听力损失。
总体并发症发生率影响了 20%的植入设备，个别设备的发生率从 6.9%到 100%不等。所有 AMEI 均记录到硬件系统故障，范围从 10%到 50%不等。替代听觉康复包括在 2 例中更换相同系统，在 3 例中使用传统助听器，在 4 例中进行 Cochlear 植入，在 2 例中进行对侧耳植入。
目前的临床经验表明，尽管大多数 AMEI 植入患者显示出成功的功能率，但并发症可能会在一定比例的病例中发生，这应该促使专业人员选择替代解决方案，从（重新）采用传统助听器开始，最终到 Cochlear 植入。
