Opto-Electrical Cochlear Implants

光电人工耳蜗

• 批准号: 10618825
• 负责人: CLAUS-PETER RICHTER
• 金额: $ 40.75万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-02-15 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10618825
• 关键词: Acoustic Nerve; Acoustic Stimulation; Acoustics; Action Potentials; Acute; American; Animal Model; Auditory; Bionics; Clinic; Clinical; Cochlea; Cochlear Implants; Collaborations; Communication; Craniotomy; Data; Development; Diameter; Electric Stimulation; Electric Wiring; Electrodes; Encapsulated; Environment; Equipment; Excision; Felis catus; Fiber Optics; Goals; Good Manufacturing Process; Hearing; Human; Hybrids; Implant; Implanted Electrodes; Industrialization; Infrared Rays; Institution; Intraoperative Monitoring; Language; Length; Light; Manufacturer; Measurement; Measures; Medical Device; Methods; Modality; Monitor; Music; Neurons; Operating Rooms; Operative Surgical Procedures; Optics; Patients; Perception; Performance; Photons; Physiologic pulse; Polishes; Preparation; Psychophysics; Pulse Rates; Radiation; Research; Risk; Risk Assessment; Saline; Scala Tympani; Scientist; Silicones; Site; Skull Base Neoplasms; Societies; Source; Specific qualifier value; Stimulus; Surgeon; System; Technology; Temperature; Testing; Time; Tissues; Translating; United States Food and Drug Administration; Work; Writing; aqueous; clinical center; deaf; design; experience; experimental study; fabrication; first-in-human; human study; implantable device; improved; in vivo; industry partner; manufacture; miniaturize; neural prosthesis; neural stimulation; next generation; novel; optical fiber; physical property; pre-clinical research; prototype; recruit; response; round window; sound; speech in noise; spiral ganglion; success; tool; tumor; waveguide

Project Summary / Abstract Our goal is to develop an optical cochlear implant (oCI) that uses photons to stimulate surviving auditory neurons in severely-to-profoundly deaf. The benefit of optical stimulation is its spatial selectivity with the potential to create significantly more independent channels to encode acoustic information and to enhance the CI users’ performance in challenging listening environments and to improve music appreciation. In previous experiments we have defined the parameter space for infrared neural stimulation (INS) in diverse animal models, including the cat. To translate the method into a clinical tool, an opto-electrical cochlear implant, we have to convert the parameter space defined for the cats to the larger cochlea of the humans. In preparation of the study we have communicated with the Food and Drug Administration (FDA) and have submitted a Q- submission for a study risk assessment for the first set of the proposed tests. The purpose of this study is to show that optical and combined opto-electrical stimulation is possible in humans using optical fibers, optical fiber bundles, and a hybrid opto-electrical cochlear implant. Furthermore, the tests will also validate that INS is possible at radiation wavelengths, which are used commercially in communication and for which the technology of optical sources and waveguides is well miniaturized and matured. Most importantly, we will use a forward masking method to validate the view that optical stimulation is spatially more selective than electrical stimulation by comparing the ability of a masking stimulus to reduce the response amplitude of a probe stimulus. Test subjects will be patients with large tumors of the skull base, who require a translabyrinthine craniotomy for tumor removal. For this surgical approach the cochlea and vestibular system will be damaged and the patients will be deaf after surgery. This surgery provides an unique opportunity to test optical stimulation in the human cochlea before it is removed during the tumor resection. Important data can be gathered, which will drive the development of an implantable opto-electrical cochlear implant system by our industrial collaborators. The measurements will take no longer than 30 minutes per patient, after which all the equipment will be removed from the surgical filed and the tumor resection surgery continues.

项目总结/摘要 我们的目标是开发一种光学人工耳蜗（oCI），使用光子刺激幸存的听觉 神经元的数量。光刺激的益处是其空间选择性， 潜在的创造明显更多的独立通道来编码声学信息，并提高 CI用户在具有挑战性的聆听环境中的表现，并提高音乐欣赏能力。前几 通过实验，我们确定了不同动物的红外神经刺激（INS）的参数空间 模型，包括猫。为了将该方法转化为临床工具，光电耳蜗植入物，我们 必须将为猫定义的参数空间转换为人类的较大耳蜗。在制备 我们已经与美国食品药品监督管理局（FDA）沟通了这项研究，并提交了一份Q- 提交第一组拟定试验的研究风险评估。本研究的目的是 显示了使用光纤、光学传感器、光学 纤维束和混合光电耳蜗植入物。此外，测试还将验证INS是 在通信中商业使用的辐射波长下， 光源和波导的技术已经很好地小型化和成熟。最重要的是，我们将使用 前向掩蔽方法，以验证光学刺激比电刺激在空间上更具选择性的观点 通过比较掩蔽刺激降低探针响应幅度的能力来确定刺激 刺激。测试对象将是患有颅底大肿瘤的患者，他们需要一个transmartine。 开颅切除肿瘤这种手术方法会损伤耳蜗和前庭系统 手术后病人会失聪这个手术提供了一个独特的机会来测试光学 在肿瘤切除术期间，在人类耳蜗被移除之前，对人类耳蜗进行刺激。重要数据可以 收集，这将推动我们的植入式光电人工耳蜗系统的发展。 工业合作者。每个患者的测量时间不超过30分钟，之后所有的 设备将从手术区域移除，肿瘤切除手术继续进行。