Böheim Klaus, Mlynski Robert, Lenarz Thomas, Schlögel Max, Hagen Rudolf
Landesklinikum St Pölten, Austria.
Acta Otolaryngol. 2012 Oct;132(10):1042-8. doi: 10.3109/00016489.2012.684701. Epub 2012 Jul 10.
The round window (RW) approach in the use of the Vibrant Soundbridge(®) (VSB) is a safe and effective treatment of conductive and mixed hearing losses for a period of more than 3 years of device use.
To investigate the long-term safety and efficacy as well as user satisfaction of patients with conductive and mixed hearing losses implanted with the VSB using RW vibroplasty.
Twelve patients with conductive and mixed hearing losses were evaluated after 40 months of daily VSB use. Safety was assessed by evaluating reports of postoperative medical and surgical complications as well as by changes in bone conduction hearing thresholds. Efficacy outcome measures included aided and unaided hearing thresholds, speech recognition in quiet and in noise and subjective benefit questionnaires.
The safety results revealed no significant medical complications. One subject experienced sudden hearing loss after 18-24 months of device use, but still continues to wear the device to her satisfaction. With regard to efficacy, there were no significant changes from short- to long-term results in aided word understanding, functional gain or speech recognition threshold, suggesting that the outcomes are stable over time. Subjective questionnaires revealed either the same or better results compared with the short-term data.
在使用振动声桥（VSB）时采用圆窗（RW）方法，对于传导性和混合性听力损失而言，在长达三年多的设备使用期内是一种安全有效的治疗方法。
研究采用RW振动成形术植入VSB的传导性和混合性听力损失患者的长期安全性、疗效以及用户满意度。
在每日使用VSB 40个月后，对12例传导性和混合性听力损失患者进行评估。通过评估术后医疗和手术并发症报告以及骨导听力阈值的变化来评估安全性。疗效指标包括助听和未助听听力阈值、安静和噪声环境下的言语识别以及主观受益问卷。
安全性结果显示无明显医疗并发症。一名受试者在设备使用18至24个月后出现突发听力损失，但仍继续佩戴该设备且感到满意。在疗效方面，从短期到长期，助听单词理解、功能增益或言语识别阈值均无显著变化，这表明随着时间推移结果是稳定的。主观问卷显示与短期数据相比结果相同或更好。
