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.

项目总结 HL是全球导致残疾的主要原因，全球估计有9810亿美元 成本。当助听器的声学放大不再是有效的治疗方法时，患者 可以接受人工耳蜗术(CI)。目前，外科医生将电极阵列穿入 螺旋耳蜗，冒着结构损伤的风险，破坏残余的声音听力并影响 总体听证结果。因此，领养率仍然非常低：符合条件的人中有5% 美国的人口。 先进光电公司(AO)正在开发一种新型的外科医生指导系统，该系统使用 微电子机械系统(MEMS)传感器阵列，将与 现有CI电极阵列设计用于检测弯曲和作用于阵列的力以发出警告 潜在风险的外科医生。使用先进的聚合物微加工技术，AO已经 生产超薄且灵活的传感器，可通过以下方式集成到CI电极 对CI电极尺寸或机械性能的影响最小。 该第一阶段提案将从制造的角度论证该系统的可行性， 可用性和监管角度。I期结果将为临床应用铺平道路 第二阶段的翻译。第一阶段项目的具体目标是： 具体目标1：用人工耳蜗术确定传感器的可靠性 电极：整个系统(CI+传感器)将反复改进，以实现健壮性和 可靠性最大化两个关键指标：1.测量可靠性；2.附件 健壮性。 具体目标2：演示传感器的有效性以提高外科医生的水平 技术：该系统的效果将通过外科医生在3D打印耳蜗中插入来验证 模特们。外科医生将系统地改变在这些试验中收集的插入技术和数据 将进行评估，以表明实时反馈允许外科医生将插入力降至最低。 具体目标3：确定监管途径和要求：一个详细的 将准备监管建议书，以涵盖硬件的预期用途、监管说明 和软件组件，以及支持安全性和有效性的研究。预先提交的文件 将为FDA关于产品的早期和全面讨论准备简报文件 发展和登记战略。