Fully implantable Otologics MET Carina device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results.
Fully implantable Otologics MET Carina device for the treatment of sensorineural hearing loss. Preliminary surgical and clinical results.
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发表时间：
2009-04
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通讯作者：
L. Bruschini;F. Forli;A. Santoro;P. Bruschini;Stefano Berrettini
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作者：
L. Bruschini;F. Forli;A. Santoro;P. Bruschini;Stefano Berrettini
中耳植入克服了传统助听器技术的一些常见问题，如反馈、信号失真、耳道阻塞等。The tolologics MET Carina, Boulder， CO， USA，是一种完全植入式助听器，旨在满足中度至重度感音神经性听力损失和正常中耳的成年人（bb0 - 18岁）的放大需求，提供对中耳听骨的机械直接刺激。最近，它也被成功地用于传导性听力损失患者。在本报告中，描述了2007年11月至2008年5月在比萨大学耳鼻喉科手术的5例中度至重度感音神经性听力损失的成人完全植入式隆托的个人手术和临床经验。平均随访时间为使用器械10.2个月（范围7-13个月）。手术在全身麻醉下进行，手术时间约为3小时，所有患者均无手术并发症。在这5例患者中，无论是空气传导还是骨传导，均未观察到术后听力阈值的明显变化，表明手术未对耳蜗造成损伤。所有患者在听力阈值、自由场和语言感知能力方面都有改善，设备功能正常，而且他们报告了主观益处。在术后不良反应方面，没有观察到器械挤压、器械失效、外部通信丢失或充电次数增加的情况。出现反馈噪声问题，4例患者通过轻微的拟合调整解决，而另1例患者则需要进行第二次手术以改变麦克风位置。目前的结果与文献报道的结果一致，证实了耳科MET Carina对于中度至重度感音神经性听力损失是可行的治疗方法，并且在选定的病例中，可能代表传统助听器的替代方案。
Middle ear implants overcome some of the common problems of conventional hearing aid technology, such as feedback, signal distortion, ear canal occlusion and associated issues. The Otologics MET Carina, Boulder, CO, USA, is a fully implantable hearing prosthesis designed to address the amplification needs of adults (> 18 years of age), with moderate to severe sensorineural hearing loss and normal middle ears, providing a mechanical direct stimulation of middle ear ossicles. Recently, it has been successfully used also in patients with conductive hearing loss. In the present report, personal surgical and clinical experience with the fully implantable Carina is described in 5 adults with moderate to severe sensorineural hearing loss, operated upon between November 2007 and May 2008 in the ENT Unit, University of Pisa. Mean follow-up was 10.2 months of device use (range 7-13). Surgery was performed under general anaesthesia, in approximately 3 hours, with no surgical complications in any of the patients. In these 5 cases, no significant post-operative variation was observed in hearing thresholds, either for air or bone conduction, indicating absence of surgical damage to the cochlea. All patients showed improvements in hearing thresholds, in free field and in speech perception abilities, with the device functioning, moreover, they reported subjective benefits. With regard to post-operative adverse effects, no cases of extrusion of the device, device failure, loss of external communication or increased charging times were observed. Problems of feedback noise occurred, which were resolved with minor fitting adjustments in 4 cases, while a second operation was required to change the microphone position in the other patient. The present results, in agreement with those reported in the literature, confirm that the Otologics MET Carina is viable treatment for moderate to severe sensorineural hearing loss and, in selected cases, may represent an alternative to conventional hearing aids.