Otology and Cochlear Implants Division, University of Pisa, Italy.
Acta Otorhinolaryngol Ital. 2009 Apr;29(2):79-85.
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.
中耳植入物克服了传统助听器技术的一些常见问题，如反馈、信号失真、耳道堵塞和相关问题。美国科罗拉多州博尔德的 Otologics MET Carina 是一种完全可植入的听力假体，旨在满足成人（> 18 岁）中度至重度感音神经性听力损失和正常中耳的放大需求，提供中耳听小骨的机械直接刺激。最近，它也成功地用于传导性听力损失的患者。在本报告中，描述了 5 例成人中度至重度感音神经性听力损失患者的个人手术和临床经验，这些患者于 2007 年 11 月至 2008 年 5 月在比萨大学耳鼻喉科接受了手术。平均随访时间为设备使用 10.2 个月（范围为 7-13 个月）。手术在全身麻醉下进行，大约 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，听力阈值均无明显的术后变化，表明耳蜗无手术损伤。所有患者的听力阈值在自由场和言语感知能力方面都有所改善，而且设备能够正常工作，他们还报告了主观获益。至于术后不良反应，未观察到设备脱出、设备故障、外部通讯丢失或充电时间增加的情况。发生了反馈噪声问题，在 4 例中通过微小的拟合调整解决，而另一名患者则需要进行第二次手术来改变麦克风位置。目前的结果与文献报道的结果一致，证实 Otologics MET Carina 是治疗中度至重度感音神经性听力损失的可行方法，在某些情况下，它可能是传统助听器的替代方法。
