Mosnier Isabelle, Sterkers Olivier, Bouccara Didier, Labassi Samia, Bebear Jean-Pierre, Bordure Philippe, Dubreuil Christian, Dumon Thibaud, Frachet Bruno, Fraysse Bernard, Lavieille Jean-Pierre, Magnan Jacques, Martin Christian, Meyer Bernard, Mondain Michel, Portmann Didier, Robier Alain, Schmerber Sébastien, Thomassin Jean-Marc, Truy Eric, Uziel Alain, Vanecloo François-Michel, Vincent Christophe, Ferrary Evelyne
AP-HP, Hôpital Beaujon, Service d'ORL, Clichy, France.
Ear Hear. 2008 Apr;29(2):281-4. doi: 10.1097/aud.0b013e3181645366.
To assess audiological performance, satisfaction rate, and side effects of 100 patients who have been using the middle ear implant Vibrant Soundbridge (VSB) for 5 to 8 yr when compared with data collected from 3 to 18 mo postsurgery.
Audiological testing and subjective evaluation using self-assessment scales were performed in 77 out of the 100 patients using the VSB for 5 to 8 years. The results were compared to data collected 3 months (audiological testing) and 18 months (self-assessment scales) after surgery. Twenty-three patients have not been evaluated for different reported reasons.
Pure-tone hearing thresholds decreased similarly in both implanted and contralateral ears. The satisfaction ratings and the functional gain provided by the VSB remained stable. Speech comprehension in quiet conditions without the VSB decreased from 56 to 37% in 5 to 8 yr, but an 81% score was achieved with the VSB.
This study demonstrates that the performance of the VSB does not deteriorate for more than 5 yr, without adverse effect. These results confirm the safety and the effectiveness of the VSB with a long-term follow-up.
评估100例使用中耳植入物Vibrant Soundbridge（VSB）5至8年的患者的听力学表现、满意率和副作用，并与术后3至18个月收集的数据进行比较。
对100例使用VSB 5至8年的患者中的77例进行了听力学测试和使用自我评估量表的主观评估。将结果与术后3个月（听力学测试）和18个月（自我评估量表）收集的数据进行比较。23例患者因不同报告原因未进行评估。
植入耳和对侧耳的纯音听力阈值下降情况相似。VSB提供的满意率和功能增益保持稳定。在5至8年中，不使用VSB时安静环境下的言语理解率从56%降至37%，但使用VSB时得分达到81%。
本研究表明，VSB的性能在超过5年的时间里不会恶化，且无不良影响。这些结果证实了VSB长期随访的安全性和有效性。
