Projects

Individualized Implants for Local Drug Delivery

Currently, no approved pharmacotherapy exists for hearing loss, mainly due to insufficient drug delivery methods. We develop patient-specific, temporary implants for local and controlled drug delivery to the inner ear via the round window niche. Our technology enables additive manufacturing of elastic, individualized implants from dexamethasone-loaded silicone based on clinical imaging. The workflow includes software-assisted segmentation, implant design, high-resolution printing, and sterilization.

In this project we set up the GMP production of the IMP, conduct the first clinical trial to proof the safety and efficacy of our implants and start spin-off activities. T Funding: Institute for Biomedical Translation (IBT) Lower Saxony IBT Lower Saxony.

Trauma-Reducing Alginate Cochlear-Implant COating (TRACO)

Cochlear implant insertion can cause friction-related trauma and inflammation, leading to postoperative loss of residual hearing. Building on prior findings, we investigate whether alginate hydrogel coating of cochlear implant electrode carriers reduces insertion forces, tissue damage, and inflammatory responses. In collaboration with Advanced Bionics, we develop a reproducible, clinically feasible coating process that yields a stable and uniform lubricating layer. Functional coated electrodes are produced and evaluated in vitro for insertion forces, coating stability, and biocompatibility, while different coating methods are systematically compared. The most technically robust and industry-compatible process with the best in vitro performance is then assessed preclinically in an in vivo guinea pig model, following regulatory guidance to support future first-in-human translation. (DFG, Project No 452405020)

ACEMg-Supplement Mediated Hearing Preservation in Cochlear Implant Patients Receiving Different Electrode Lengths

This is a follow-up project of the European Union funded project PROHEARING which was finalized in summer 2016. In PROHEARING we investigated the effect of an investigational medicinal product called Soundbites. The indication for a cochlear implant has expanded to patients with some residual hearing. Shorter and thinner 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 trauma and the presence of this foreign body inside the cochlea, may lead to free radical formation and reduced blood perfusion of the cochlea which can result in a loss of residual hearing. This new project is a single center, randomized, placebo-controlled, double-blind phase II clinical trial investigating the effect of free radial scavengers and a vasodilator on the residual hearing of 140 CI-patients. Funding: MHH Förderstiftung Plus