Oto-Rhino-Laryngology Surgery Clinic, World Hearing Center, Institute of Physiology and Pathology of Hearing, Mokra 17, Warsaw/Kajetany, 05-830 Nadarzyn, Poland.
Teleaudiology and Screening Department, World Hearing Center, Institute of Physiology and Pathology of Hearing, Mokra 17, Warsaw/Kajetany, 08-830 Nadarzyn, Poland.
Eur Arch Otorhinolaryngol. 2020 Nov;277(11):3013-3019. doi: 10.1007/s00405-020-06031-6. Epub 2020 May 13.
To evaluate the long-term audiological outcomes and safety of the latest generation of middle ear transducer (MET) among a group of Polish patients.
Ten patients aged 48-72 years with bilateral sensorineural hearing loss (n = 8) and mixed hearing loss (n = 2) were included in this study. Pure tone audiometry, sound thresholds, word recognition scores in quiet and speech reception thresholds in noise were assessed. Medical and technical complication information was gathered.
All the patients underwent unilateral implantation with the latest generation Cochlear MET between 2014 and 2016. Mean length of follow-up was 3.7 years. Compared to the unaided condition, the implant provided significant functional gain (mean M = 26.1 dB) at 12 months follow-up. Compared to before surgery, average word recognition in quiet at 65 dB and at 80 dB SPL, as well as speech reception threshold in noise, were significantly better at 12 months. However, postoperative air conduction thresholds 6 months after implantation worsened by 10.3 dB (standard deviation SD = 5.8 dB). Postoperatively, three patients had skin problems around the processor, and one of them completely resigned from using the device 5 months after activation. Technical failures occurred in 4 cases. There were 9 out of 10 patients who still used the MET, but only 5 of them used the processor regularly (every day).
Despite changes in the transducer implemented by the manufacturer, we observed a significant number of adverse events in users of the latest generation of MET.
评估新一代中耳换能器（MET）在波兰患者中的长期听力学效果和安全性。
本研究纳入了 10 名年龄在 48-72 岁之间的双侧感音神经性听力损失患者（n=8）和混合性听力损失患者（n=2）。评估纯音听阈、声阈、安静环境下的言语识别得分和噪声环境下的言语接受阈。收集了医疗和技术并发症信息。
所有患者均于 2014 年至 2016 年期间接受了单侧最新一代 Cochlear MET 植入。平均随访时间为 3.7 年。与未佩戴状态相比，植入后 12 个月时提供了显著的功能增益（平均 M=26.1dB）。与术前相比，65dB 和 80dB SPL 时的安静环境下平均言语识别率以及噪声环境下的言语接受阈在 12 个月时显著提高。然而，植入后 6 个月时的气导阈值恶化了 10.3dB（标准差 SD=5.8dB）。术后有 3 名患者处理器周围出现皮肤问题，其中 1 名患者在激活后 5 个月完全放弃使用该设备。有 4 例发生技术故障。有 9 名患者仍在使用 MET，但只有 5 名患者定期使用处理器（每天）。
尽管制造商对换能器进行了改进，但我们观察到最新一代 MET 用户出现了大量不良事件。
