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.

项目摘要 HL是全球残疾的主要原因，负责全球估计$ 981B 费用。当助听器的声学扩增不再是有效的治疗方法时，患者 可以收到人工耳蜗（CI）。目前，外科医生将电极阵列螺纹到 螺旋耳蜗，冒着结构性损害的风险，破坏了残留的声学听力和影响 总体听力结果。因此，采用率仍然非常低：占合格条件的5％ 在美国的人口。 Advanced Optronics（AO）正在使用A开发新型的外科医生指导系统 微电机电系统（MEMS）传感器阵列将与 现有的CI电极阵列设计，以检测弯曲和作用在阵列上的力 潜在风险的外科医生。使用高级聚合物微分解技术，AO具有 产生的超薄和柔性传感器，可以将其掺入带有CI电极 对CI电极尺寸或力学的影响最小。 该阶段I建议将证明系统从制造中的可行性， 可用性和监管观点。第一阶段的结果将为临床铺平道路 第二阶段的翻译。 I阶段项目的具体目的是： 特定目标1：用人工耳蜗确定传感器可靠性 电极：完整的系统（CI +传感器）将迭代改善稳健性和 可靠性以最大化两个关键指标：1。测量可靠性和2。附件 鲁棒性。 特定目标2：展示传感器有效性以改善外科医生 技术：该系统的功效将通过外科医生插入3D印刷人心 型号。外科医生将在这些试验中有系统地改变插入技术和数据 将评估以表明实时反馈允许外科医生最大程度地减少插入力。 特定目标3：确定监管途径和要求：详细 监管建议将准备涵盖预期用途，硬件的监管描述 以及软件组件，以及支持安全性和有效性的研究。提前提取 简报文件将为早期且全面的FDA讨论做好准备 开发和注册策略。