PFI-TT: Translation of a Microcoil-Based Stimulating Array for Cochlear Implants

这个PFI项目的更广泛的影响/商业潜力是加速助听器的制造，即人工耳蜗的制造。与仅仅使声音变得更响亮的助听器不同，人工耳蜗会通过手术植入人的耳朵，并以大脑感知为声音的方式激活听力(听觉)神经。目前，在美国，人工耳蜗的使用量比正常情况下要少，甚至更多的儿童可以从这种设备中受益。使用有限的原因包括对该设备的认识和成本、手术和后续护理。这一PFI项目的实施将为使用微线圈制造人工耳蜗提供一种新的方法。此外，通过以类似于印刷电子设备的方式制造设备，可以实现显著的成本降低，同时与传统的人工耳蜗植入技术自然集成。该项目还将通过本科生和研究生的推广和参与来提高对人工耳蜗的认识，重点放在代表性较低的群体上。拟议的项目追求一种新的方法，以开发可以安装在人耳内的微线圈，作为人工耳蜗植入物的一部分，即人工耳蜗阵列。为了生产这种器件，我们计划通过一种新的制造方法来克服技术转让障碍，该方法依赖于添加剂制造和柔性电子技术的最新进展，以便在聚合物基板上以三维方式快速写入(打印)导电迹线。然后，我们将设备完全封装在生物兼容聚合物中，以实现用于实验室和体外测试的概念验证微线圈。这些设备将使我们能够克服现有的知识差距，通过工作台和神经细胞培养测试，在微线圈尺寸、与目标听觉神经元的接近程度以及刺激参数方面。科学上的价值在于证明了微线圈可以通过磁感应电场引起集中的神经活动，并使听神经元能够选择性地激活。我们将拥有基准数据，在此基础上构建我们的商业化技术案例。由工程师、临床医生、商业化导师和领域专家合作者组成的强大的多学科团队将合作进行翻译，目标是为患有严重到严重听力损失的儿童和成人实现改变生活的干预措施。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this PFI project is to accelerate the manufacture of a hearing assistive device, a cochlear implant. In contrast to hearing aids that simply make sounds louder, a cochlear implant is surgically placed into the human ear and activates the hearing (auditory) nerve in a way that the brain perceives as sound. Presently, cochlear implants are used less than they can be in the United States, and even more children could benefit from the device. The reasons for the limited utilization include awareness and costs of the device, surgery and follow up care. The pursuit of this PFI project will offer a new way to make cochlear implants with microcoils. Furthermore, by creating the devices in a way similar to printed electronics, dramatic cost reduction may be realized, along with the natural integration with conventional cochlear implant technologies. This project will also improve the awareness of cochlear implants through outreach and engagement of undergraduate and graduate students, with a focus on underrepresented groups.The proposed project pursues a novel method to develop microcoils that can fit within the human ear as part of a cochlear implant, the cochlear array. To produce this device, we plan to overcome technology transfer barriers through a novel manufacturing approach relying upon recent advances in additive manufacturing and flexible electronics to rapidly write (print) conductive traces on a polymeric substrate in three-dimension. We then encapsulate the device fully in a biocompatible polymer to realize proof-of-concept microcoils for bench and in-vitro testing. These devices will enable us to overcome the existing knowledge gap in microcoil dimensions, proximity to target auditory neurons, and stimulus parameters through bench and neural cell culture testing. The scientific merit is the demonstration that microcoils can elicit focused neural activity, via magnetically induced electric fields, and enable selective activation of auditory neurons. We will have the baseline data upon which to build our technical case for commercialization. A strong multidisciplinary team consisting of engineers, clinicians, commercialization mentor and domain expert collaborators will partner to pursue translation with the goal of achieving a life-changing intervention for children and adults suffering from severe-to-profound hearing loss.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.