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

Polymers (Basel). 2022 Apr 26;14(9):1766. doi: 10.3390/polym14091766.

Abstract

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.

Keywords: actuators; biocompatibility; cochlear implants; curvature; self-bending electrode arrays; sensorineural hearing loss; silicone rubber–hydrogel composites; swelling behavior.

Grants and funding

The study presented in this paper is funded by “the Cluster of Excellence Hearing4All (grant 580 number EXC 1077/1. and EXC2077) and by the AiF Projekt GmbH represented by the 581 Federal ministry for Economic Affairs and Energy (grant number ZF4412702SL7)”.