Medical-Grade Silicone Rubber-Hydrogel-Composites for Modiolar Hugging Cochlear Implants.

The gold standard for the partial restoration of sensorineural hearing loss is cochlear implant surgery, which restores patients' speech comprehension. The remaining limitations, e.g., music perception, are partly due to a gap between cochlear implant electrodes and the auditory nerve cells in the modiolus of the inner ear. Reducing this gap will most likely lead to improved cochlear implant performance. To achieve this, a bending or curling mechanism in the electrode array is discussed. We propose a silicone rubber-hydrogel actuator where the hydrogel forms a percolating network in the dorsal silicone rubber compartment of the electrode array to exert bending forces at low volume swelling ratios. A material study of suitable polymers (medical-grade PDMS and hydrogels), including parametrized bending curvature measurements, is presented. The curvature radii measured meet the anatomical needs for positioning electrodes very closely to the modiolus. Besides stage-one biocompatibility according to ISO 10993-5, we also developed and validated a simplified mathematical model for designing hydrogel-actuated CI with modiolar hugging functionality.