Trauma-Reducing Alginate Cochlear-Implant COating (TRACO)

感觉神经性耳聋患者的标准治疗方法是人工耳蜗术。在过去的十年里，人工耳蜗术(CI)的适应症已经扩展到低频残留听力的患者。无创电极的设计是为了保护植入耳中的残余听力。然而，将电极阵列插入耳蜗会造成潜在的机械插入损伤、术中摩擦力以及耳蜗内异物的存在，可能会导致残留听力的丧失。我们推测，通过在ET上涂上一层水凝胶，如海藻酸盐，可以减少术后炎症过程和耳壳内组织损伤，这可以更好地保留剩余听力和改善语音理解。这个项目的主要焦点是更详细地研究这一工作假说。与工业合作伙伴先进仿生公司合作，我们将开发一种海藻酸盐-CI-涂层技术，在商业开发方面处于市场前水平。在体外进行了插入力修饰以及涂层的生物相容性和稳定性的研究。对不同的涂层工艺进行了测试和比较。最后，也是最可行的包衣技术，在体外获得了最好的结果，在植入和慢性刺激的豚鼠体内研究中进行了临床前测试。测试将在与主管当局的反馈循环中进行，以实施他们在进行实验时的建议，以最终使实验数据符合在这一翻译的临床前项目之后应用首个男性试验的监管必要性。

The standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. Within the last decade the indication for a cochlear implant (CI) has expanded to patients with residual hearing in the lower frequencies. Atraumatic electrodes have been designed to preserve the residual hearing in the implanted ear. However, the insertion of the electrode array into the cochlea, with potential mechanical insertion trauma, intraoperative frictional forces and the presence of this foreign body inside the cochlea, may lead to loss of residual hearing. We postulated that by coating the ET with a hydrogel such as alginate, a reduction in post-operative inflammatory processes and intracochlear tissue damage can be achieved and that this enables better residual hearing preservation and improved speech understanding. The main focus of this project is to investigate this working hypothesis in more detail. In cooperation with the industrial partner Advanced Bionics we will develop an alginate-CI- coating-technique at a pre-market level with regard to commercial exploitation. In vitro studies are conducted on insertion force modification and on the biocompatibility and the stability of the coating. Different coating processes are tested and compared. The final, most feasible coating technique with the best results obtained in vitro is tested preclinically in an in vivo study on implanted and chronically stimulated guinea pigs. The testing will be conducted in feedback loop with the competent authorities to implement their suggestions when conducting the experiments to finally have experimental data fitting the regulatory necessities for application of a first in men trial after this translational pre-clinical project.