Development of an AMF Orion/Blackrock HD-USEA based 60/128 channel implantable wireless simulator system for human auditory nerve implants

开发基于 AMF Orion/Blackrock HD-USEA 的 60/128 通道植入式无线模拟器系统，用于人类听觉神经植入

• 批准号: 10454504
• 负责人: Robert Jay Greenberg
• 金额: $ 74.86万
• 依托单位: BLACKROCK MICROSYSTEMS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10454504
• 关键词: Development; AMF; Orion; Blackrock; HD

Abstract The development of implantable high channel electronics interfacing with the central and peripheral nervous system has been a continuing effort for decades covering a wide range of applications. Reliable and clinically proven high channel solutions with hermetic encapsulation of the electronics that would be suitable for the use in a Cochlear or auditory nerve have so far not been demonstrated. The project aims to develop and translate a novel clinical high (60-128) channel implantable programmable stimulator (IPS) for use in Cochlear (CI) and auditory nerve (ANI) implants to expand the useable parameter space (electrode count, tonal range, lower stimulation threshold) far beyond current limits. In this project we will evaluate performance, biocompatibility and safety of a new chronically implantable can and programmable stimulator with high channel feedthrough and assembly for the use in a high channel cochlear and auditory nerve implant that uses the high-density Utah Slant Electrode Array (HD-USEA). The HD-USEA is used as penetrating auditory nerve electrode in a new type of intracranial auditory prosthesis that targets the auditory nerve en route to the brainstem in order to substantially improve hearing performance over the current standard of care, the cochlear implant (CI) (NIH 1UG3NS107688-01). Clinical feasibility and value in human subjects will be demonstrated in a new high channel auditory prosthesis being developed for use in human subjects under an existing UG3/UH3 grant. The current approach is however limited in the ability to use the potentially far higher electrode channel count and subsequent tonal range and resolution due to the limited channel count (12) of the conventional (MED-EL Synchrony) CI stimulator. While this approach is a strength of the UG3/UH3 project that combines existing clinically proven products into one new system as the fastest and lowest risk path towards first in human demonstration, it falls short in using the unique capabilities of the HD- USEA architecture or other higher channel CI electrodes.

摘要 植入式高通道电子对接中央和中枢板的研究进展 几十年来，周围神经系统一直在努力，涵盖了广泛的 申请。可靠且经临床验证的高通道解决方案，采用密封封装 到目前为止，适合用于耳蜗神经或听神经的电子器件还没有 已经被证明了。 该项目旨在开发和翻译一种新的临床高(60-128)可植入通道 可编程刺激器(IPS)用于人工耳蜗(CI)和听神经(ANI)植入物 扩展可用参数空间(电极数、音调范围、较低刺激阈值) 远远超出了目前的限制。在这个项目中，我们将评估性能、生物兼容性和安全性 一种新型可长期植入的高通道馈通可编程刺激器的研制 以及用于使用高通道耳蜗神经和听神经植入物的组件 高密度犹他州倾斜电极阵列(HD-USEA)。HD-USEA用于穿透 听神经电极在一种新型以听觉为靶点的颅内听觉假体中的应用 神经通向脑干，以显著改善听力 目前的护理标准是人工耳蜗术(CI)(NIH 1UG3NS107688-01)。临床可行性 而人类受试者的价值将在一种新的高通道听觉假体中得到展示 根据现有的UG3/UH3赠款开发用于人类受试者。目前的做法是 然而，在使用可能高得多的电极通道计数和 随后的色调范围和分辨率是由于传统的 (Med-El Synchrony)CI刺激器。虽然这种方法是UG3/UH3项目的一个优势， 将现有的经临床验证的产品整合到一个新系统中，速度最快，风险最低 在人类演示中通向第一的道路，它在使用HD的独特功能方面做得不够- USEA架构或其他更高通道CI电极。