Tringali Stéphane, Pergola Nick, Berger Paul, Dubreuil Christian
Service d'Oto-neurochirurgie, Hospices Civils de Lyon, Centre hospitalier Lyon Sud, 69495 Pierre-Benite Cedex, France.
Auris Nasus Larynx. 2009 Jun;36(3):353-8. doi: 10.1016/j.anl.2008.09.003. Epub 2008 Nov 13.
To demonstrate the safety and efficacy of the Otologics Carina Middle Ear Transducer for treatment of mixed hearing loss through a case report.
A Carina fully implantable device with the MET transducer for conductive applications was implanted in a 48-year-old woman suffering from right mixed hearing loss (mean PTA loss: 80 dB). A facial recess approach was used to access the middle ear. Sclerotic tissue obliterated the stapes footplate so the approach selected was to place the transducer directly on the round window. The mounting bracket was placed on the mastoid and the prosthesis was advanced toward the round window until the Otologics surgical software indicated contact. Effective stimulation of the cochlea was confirmed intraoperatively by ABR monitoring.
Postoperative unaided PTA thresholds were unchanged after surgery. When the implant was activated, the mean PTA functional gain was 39 dB.
DISCUSSION-CONCLUSION: The capability of the Carina MET Ossicular stimulator to provide appropriate gain relative to the degree of hearing loss indicates that the device offers a viable treatment option for mixed hearing loss. However, these promising initial results establish the need for future work on two fronts: (1) further studies are needed including a greater number of patients to confirm these preliminary results; (2) a long term follow-up must be carried out to detect any possible cochlear adverse effects on the cochlea, in particular on the basilar membrane.
通过病例报告证明Otologics Carina中耳换能器治疗混合性听力损失的安全性和有效性。
将带有用于传导性应用的MET换能器的Carina完全植入式装置植入一名患有右耳混合性听力损失（平均纯音听阈损失：80 dB）的48岁女性体内。采用面隐窝入路进入中耳。硬化组织使镫骨底板闭塞，因此选择的方法是将换能器直接放置在圆窗上。将安装支架置于乳突上，将假体向圆窗推进，直到Otologics手术软件显示接触。术中通过听性脑干反应监测确认对耳蜗的有效刺激。
术后未助听纯音听阈术后无变化。当植入装置开启时，平均纯音听阈功能增益为39 dB。
讨论-结论：Carina MET听骨刺激器相对于听力损失程度提供适当增益的能力表明该装置为混合性听力损失提供了一种可行的治疗选择。然而，这些有前景的初步结果表明未来需要在两个方面开展工作：（1）需要进一步研究，包括纳入更多患者以证实这些初步结果；（2）必须进行长期随访，以检测对耳蜗，特别是对基底膜可能产生的任何耳蜗不良反应。
