Trauma-Reducing Alginate Cochlear-Implant COating (TRACO)

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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.