Shape-adaptive cochlear implant electrode arrays (R44DC022220) – Project Grant to Qualia Oto, Inc.

Abstract: During this phase II sbir effort, qualia OTO will develop and validate shape-adaptive cochlear implant (CI) electrode arrays as a new solution for achieving simultaneous atraumatic cochlear implantation and optimal electrode placement. Upon successful completion of this grant, qualia OTO will be on course to secure an FDA master file and solidify a path toward commercialization as we continue to partner with one of the three major CI companies in the world. The incorporation of our novel electrode arrays into currently offered cochlear implants could provide safer surgeries and more resolute implant functionality for one million new patients over the coming dozen years. Historically, lateral wall electrodes have been the preferred CI electrode option due to the higher likelihood of achieving atraumatic insertion and preserving residual hearing. However, placing electrodes closer to the modiolus of the cochlea can offer potential performance benefits, such as more focal stimulation and reduced current spread due to a shorter distance from the electrode to the spiral ganglion neuron target. Unfortunately, conventional perimodiolar electrodes suffer from higher rates of trauma and electrode displacement (translocation), negatively affecting the preservation of residual hearing. Qualia OTO is addressing this long-standing challenge by utilizing shape-memory polymers (SMP) as a dynamic element that induces programmed self-curling of the CI electrode arrays in the inner ear. This approach facilitates gentle and gradual repositioning of the implanted arrays from the lateral wall to the modiolar wall without trauma. By combining the advantages of both lateral wall electrodes (i.e., atraumatic insertion) and perimodiolar electrodes (i.e., focal placement), the proposed technology enables a combination of reliable CI electrode insertion and improved sound perception. Our phase II effort encompasses fabricating shape-adaptive CI electrode arrays and conducting an implantation study in a sheep model, evaluating the SMP longevity under accelerated aging, and assessing the full biocompatibility of the SMP in accordance with regulatory standards. We will rigorously validate our approach through mechanical, chemical, electrophysiological, and imaging analyses, and establish the dataset to progress toward commercialization.

Shape-adaptive cochlear implant electrode arrays

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