Knölke Nicole, Murawski Dawid, Wardenga Nina, Busch Susan, Maier Hannes, Lenarz Thomas
Department of Otorhinolaryngology German Hearing Center and Institute of Audioneurotechnology (VIANNA), Hannover Medical School Hannover Germany.
Cluster of Excellence "Hearing4all" Hannover Germany.
Laryngoscope Investig Otolaryngol. 2022 May 28;7(3):840-846. doi: 10.1002/lio2.812. eCollection 2022 Jun.
The Hannover Coupler version 2 (HC2) was designed to (1) adapt the coupler geometry to the round window (RW) niche (2) to stabilize the floating mass transducer, and (3) to control static coupling forces to the RW. First audiological outcomes with a custom-made HC2 are reported here.
Ten patients were enrolled in our site-initiated, prospective study. To assess audiological outcomes up to 6 months, preoperative and postoperative hearing thresholds, word recognition score (WRS) at 65 dB SPL and the speech recognition threshold in quiet and noise were performed. The effective gain (EG) and the coupling efficiency were calculated.
One revision surgery had to be performed during the study period and a significant, but clinically not relevant bone conduction thresholds change was observed at 4 and 6 kHz at 6-month follow-up. At 6 months, the median WRS ( = 10) improved significantly from 0% to 80%. The median speech reception threshold in noise improved significantly from 11.6 to -2.4 dB SNR, and in quiet significantly from 79.6 to 44.4 dB SPL. The average EG of -1.3 dB indicated a closure of the air bone gap. The determined average coupling efficiency of 23.3 dB was within the acceptance range suggested by the manufacturer.
For patients with mixed hearing loss and multiple ear surgeries, the HC2 provided good and stable speech recognition results exceeding published results of RW coupling without a coupler or coupling with the RW soft coupler.
汉诺威耦合器2型（HC2）的设计目的是：（1）使耦合器几何形状适应圆窗龛；（2）稳定浮动质量传感器；（3）控制与圆窗的静态耦合力。本文报告了定制HC2的首批听力学结果。
10名患者参与了我们机构发起的前瞻性研究。为评估长达6个月的听力学结果，进行了术前和术后听力阈值、65dB声压级下的单词识别分数（WRS）以及安静和噪声环境下的言语识别阈值测试。计算了有效增益（EG）和耦合效率。
研究期间进行了1次翻修手术，6个月随访时在4kHz和6kHz观察到骨导阈值有显著但临床无相关性的变化。6个月时，中位数WRS（n = 10）从0%显著提高到80%。噪声环境下的中位数言语接受阈值从11.6dB信噪比显著提高到-2.4dB信噪比，安静环境下从79.6dB声压级显著提高到44.4dB声压级。平均EG为-1.3dB表明气骨导间距缩小。确定的平均耦合效率为23.3dB，在制造商建议的可接受范围内。
对于混合性听力损失且接受过多次耳部手术的患者，HC2提供了良好且稳定的言语识别结果，超过了未使用耦合器或使用圆窗软耦合器时已发表的圆窗耦合结果。
