Auditory Implant Unit, Department of Otorhinolaryngology, Hospital CUF Porto, Porto, Portugal.
Serviço de Otorrinolaringologia-Hospital Cuf Porto, Estrada da Circunvalação 14341, 4100-180, Porto, Portugal.
Eur Arch Otorhinolaryngol. 2019 Oct;276(10):2775-2781. doi: 10.1007/s00405-019-05557-8. Epub 2019 Jul 24.
The aim of this study was to assess the first outcomes of a fully implantable active middle ear device.
Retrospective observational nonrandomized group study.
Private hospital. Fifteen patients underwent device implantation between December 2014 and June 2017. The pre-operative and post-operative air conduction (AC) and bone conduction (BC) thresholds were evaluated. The functional gain, speech perception in silence and in noise, and localization abilities were also analyzed.
Sixteen active middle ear implantations were performed. Post-operatively, the mean pure tone thresholds were 50.5 dB ( ± 12.64) for BC and 64.9 dB ( ± 15.36) for AC. No differences were found between the post-operative and pre-operative audiometric thresholds before activating the system (p > 0.05). Post-operatively, the mean thresholds in the free field after the device was activated were 46.8 dB, 45.75 dB, 42.6 dB, and 43.38 dB at 1, 3, 6, and 12 months, respectively. The global results of speech understanding in silence were 50.7 dB, 47.18 dB, 42 dB, and 42 dB for 1, 3, 6, and 12 months, respectively. Patients with mixed hearing loss had better results than those with sensorineural hearing loss. Speech discrimination in noise and localization was improved.
Despite the small number of patients, our results confirmed that this fully implantable active middle ear device is a viable treatment for patients with moderate-to-severe sensorineural hearing loss who cannot or do not want to use traditional hearing aids for clinical or cosmetic reasons.
本研究旨在评估一种完全可植入式主动中耳装置的初步结果。
回顾性观察性非随机组研究。
私人医院。2014 年 12 月至 2017 年 6 月，15 例患者接受了装置植入。评估了术前和术后的气导（AC）和骨导（BC）阈值。还分析了功能增益、安静和噪声下的言语感知以及定位能力。
进行了 16 例主动中耳植入术。术后，BC 的平均纯音阈值为 50.5dB（±12.64），AC 为 64.9dB（±15.36）。在激活系统之前，术后和术前听力阈值之间没有差异（p＞0.05）。术后，设备激活后在自由场中的平均阈值分别为 1、3、6 和 12 个月时的 46.8dB、45.75dB、42.6dB 和 43.38dB。安静时言语理解的总体结果分别为 50.7dB、47.18dB、42dB 和 42dB，1、3、6 和 12 个月。混合性听力损失患者的结果优于感音神经性听力损失患者。噪声下的言语辨别力和定位能力得到改善。
尽管患者数量较少，但我们的结果证实，对于因临床或美容原因无法或不愿使用传统助听器的中重度感音神经性听力损失患者，这种完全可植入式主动中耳装置是一种可行的治疗方法。
