Determining reliability and efficacy of intraoperative sensors to reduce structural damage during cochlear implantation

确定术中传感器的可靠性和有效性，以减少人工耳蜗植入期间的结构损伤

• 批准号: 10760827
• 负责人: Jay W Reddy
• 金额: $ 27.49万
• 依托单位: ADVANCED OPTRONICS, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10760827
• 关键词: 3D Print; Acoustic Nerve; Acoustic Stimulation; Acoustics; Address; Adoption; Affect; American; Auditory Threshold; Benefits and Risks; Biomedical Engineering; Cadaver; Characteristics; Clinical; Cochlea; Cochlear Implants; Cochlear implant procedure; Computer software; Contracts; Custom; Data; Dementia; Dental; Development; Devices; Drops; Effectiveness; Electric Capacitance; Electrical Engineering; Electrodes; Electronics; Eligibility Determination; Environment; Evaluation; Failure; Feedback; Film; Health Technology; Hearing; Hearing Aids; Implant; Implantation procedure; Implanted Electrodes; Manufacturer; Measurable; Measurement; Measures; Mechanics; Microfabrication; Modeling; Operative Surgical Procedures; Outcome; Patient-Focused Outcomes; Patients; Persons; Phase; Polymers; Population; Procedures; Program Development; Quality of life; Regulatory Pathway; Reporting; Research; Research Personnel; Residual state; Risk; Safety; Small Business Innovation Research Grant; Social isolation; Software Design; Speech Perception; Surgeon; System; Techniques; Technology; Temporal bone structure; Testing; Thinness; Time; Translations; Trauma; Work; aqueous; biomaterial compatibility; clinical translation; commercialization; cost; design; dexterity; disability; effective therapy; effectiveness testing; electric field; experience; fabrication; flexibility; hearing impairment; implantation; implanted sensor; improved; meetings; multidisciplinary; new technology; novel; pre-clinical; product development; prototype; safety testing; sensor; side effect; success; surgery outcome; timeline; usability

PROJECT SUMMARY HL is a leading cause of disability worldwide, responsible for an estimated $981B in global costs. When acoustic amplification of hearing aids is no longer an effective treatment, patients can receive a cochlear implant (CI). Currently, the surgeon threads the electrode array into the spiral cochlea, risking structural damage that destroys residual acoustic hearing and impacts overall hearing outcomes. Consequently, adoption rates remain extremely low: 5% of the eligible population in the US. Advanced Optronics (AO) is developing a novel surgeon guidance system using a microelectromechanical system (MEMS) sensor array that will be seamlessly integrated with existing CI electrode array designs to detect bending and forces acting on the array to warn surgeons of potential risks. Using advanced polymer microfabrication techniques, AO has produced ultra-thin and flexible sensors that can be incorporated into CI electrodes with minimal impact on the CI electrode size or mechanics. This Phase I proposal will demonstrate the feasibility of the system from a fabrication, usability, and regulatory perspective. The Phase I results will pave the way for clinical translation during Phase II. The Specific Aims for the Phase I project are: Specific Aim 1: Determining Sensor Reliability with a Cochlear Implant Electrode: The complete system (CI + Sensor) will be iteratively improved for robustness and reliability to maximize two key metrics: 1. Measurement reliability, and 2. Attachment robustness. Specific Aim 2: Demonstrating Sensor Effectiveness to Improve Surgeon Technique: The system's efficacy will be validated via surgeon insertion in 3D printed cochlear models. Surgeons will systematically vary insertion technique and data collected in these trials will be evaluated to show that real-time feedback allows surgeons to minimize insertion forces. Specific Aim 3: Determining Regulatory Pathway and Requirements: A detailed regulatory proposal will be prepared to cover Intended Use, regulatory descriptions of hardware and software components, and studies to support safety and effectiveness. A Pre-Submission briefing document will be prepared for an early and comprehensive FDA discussion on product development and registration strategies.

项目概要 HL 是全球残疾的主要原因，估计造成全球 981B 美元的损失 成本。当助听器的声音放大不再是有效的治疗方法时，患者 可以接受人工耳蜗 (CI)。目前，外科医生将电极阵列旋入 螺旋耳蜗，存在结构损坏的风险，会破坏残余的听觉和影响 总体听力结果。因此，采用率仍然极低：符合条件的人只有 5% 美国的人口。 Advanced Optronics (AO) 正在开发一种新型外科医生引导系统，该系统使用 微机电系统 (MEMS) 传感器阵列将与 现有的 CI 电极阵列设计可检测弯曲和作用在阵列上的力以发出警告 潜在风险的外科医生。采用先进的聚合物微加工技术，AO 生产超薄且灵活的传感器，可集成到 CI 电极中 对 CI 电极尺寸或机械结构的影响最小。 该第一阶段提案将证明该系统从制造到制造的可行性， 可用性和监管角度。 I期结果将为临床铺平道路 第二阶段的翻译。一期项目的具体目标是： 具体目标 1：确定人工耳蜗传感器的可靠性 电极：整个系统（CI + 传感器）将迭代改进，以提高稳健性和 可靠性，以最大限度地提高两个关键指标：1. 测量可靠性，2. 附件 鲁棒性。 具体目标 2：展示传感器的有效性以提高外科医生的水平 技术：该系统的功效将通过外科医生插入 3D 打印的耳蜗来验证 模型。外科医生将系统地改变插入技术和在这些试验中收集的数据 将进行评估，以表明实时反馈可以使外科医生最大限度地减少插入力。 具体目标 3：确定监管途径和要求：详细的 将准备监管提案，涵盖硬件的预期用途、监管描述 和软件组件，以及支持安全性和有效性的研究。预提交 将为 FDA 对产品进行早期和全面的讨论准备简报文件 开发和注册策略。