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

这个PFI项目更广泛的影响/商业潜力是加速听力辅助设备，人工耳蜗的制造。与助听器不同的是，人工耳蜗植入物通过手术植入人耳，并以大脑感知声音的方式激活听觉（听觉）神经。目前，人工耳蜗的使用比美国少，更多的儿童可以从该设备中受益。使用有限的原因包括对器械的认识和成本、手术和随访护理。这个PFI项目的追求将提供一种新的方法来制造带有微线圈的人工耳蜗。 此外，通过以类似于印刷电子器件的方式创建设备，可以实现显著的成本降低，沿着与传统耳蜗植入技术的自然集成。该项目还将通过对本科生和研究生的宣传和参与来提高对人工耳蜗植入的认识，重点关注代表性不足的群体。拟议的项目追求一种新的方法来开发可以作为人工耳蜗植入物（耳蜗阵列）的一部分安装在人耳内的微线圈。为了生产这种设备，我们计划通过一种新的制造方法来克服技术转移障碍，这种方法依赖于增材制造和柔性电子产品的最新进展，以便在三维聚合物基板上快速写入（打印）导电迹线。然后，我们将设备完全封装在生物相容性聚合物中，以实现用于实验室和体外测试的概念验证微弹簧圈。这些设备将使我们能够通过实验室和神经细胞培养测试克服微弹簧圈尺寸、目标听觉神经元接近度和刺激参数方面的现有知识差距。其科学价值在于证明微线圈可以通过磁感应电场引起集中的神经活动，并能够选择性激活听觉神经元。我们将有基准数据，在此基础上建立我们的商业化技术案例。一个由工程师、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，目标是为患有重度至极重度听力损失的儿童和成人实现改变生活的干预。该奖项反映了NSF的法定使命，并通过使用基金会的智力价值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.