Zahnert Thomas, Mlynski Robert, Löwenheim Hubert, Beutner Dirk, Hagen Rudolf, Ernst Arneborg, Zehlicke Thorsten, Kühne Hilke, Friese Natascha, Tropitzsch Anke, Luers Jan Christoffer, Todt Ingo, Hüttenbrink Karl-Bernd
Department of Medicine, Clinic of Otorhinolaryngology, Head and Neck Surgery, Technical University of Dresden, Dresden, Germany,
Department of Otorhinolaryngology, Plastic, Aesthetic and Reconstructive Head and Neck Surgery, Comprehensive Hearing Center, University of Würzburg, Würzburg, Germany.
Audiol Neurootol. 2018;23(6):316-325. doi: 10.1159/000495560. Epub 2019 Jan 16.
To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant.
This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects.
Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively.
A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery.
评估四种不同的振动成形耦合器（圆窗、卵圆窗、CliP和贝尔耦合器）与有源中耳植入物联合使用时的长期安全性和性能。
这是一项多中心、前瞻性长期研究，包括5家德国医院。最初招募了30名患有传导性或混合性听力损失的成年受试者参与研究，其中24名纳入最终分析，有长达36个月的术后随访数据。术前和术后测量骨传导和气传导以评估安全性。将术后助听声场阈值和弗赖堡单音节词识别分数与植入前未助听的结果进行比较，以确认性能。额外的言语测试比较了术后未助听与助听的结果。为了确定患者满意度，对所有受试者使用了为传统助听器使用情况开发的既定生活质量问卷。
在整个研究期间，术后平均骨传导阈值保持稳定。所有研究耦合器的平均功能增益在12个月时为38.5±11.4 dB HL，在36个月时为38.8±12.5 dB HL。在65 dB SPL时，平均单词识别分数从未助听时的2.9%提高到助听时的64.2%至67.1%。术后安静环境下的平均言语接受度（或句子中50%的单词理解度）显示，在36个月时，与未助听状态相比，言语可懂度提高了17.8±12.4 dB SPL。信噪比在未助听状态的基础上提高了5.9±7.2 dB SNR。国际助听器量表得分非常积极，反映出较高的主观设备满意度。
所有耦合器均有显著改善，术后12个月和36个月的听力学性能无显著差异。
