IMPLANTABLE MIDDLE EAR HEARING DEVICE

植入式中耳听力装置

• 批准号: 3218523
• 负责人: WEN H KO
• 金额: $ 10.73万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1992
• 资助国家: 美国
• 起止时间: 1992-12-01 至 1995-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3218523
• 关键词: auditory ossicles; auditory stimulus; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; cats; ear /hearing prosthesis; implant; middle ear; titanium

Based on research results obtained on partially implantable middle ear hearing assistive device, a three year multidisciplinary research is proposed with the objectives to improve the design, to fabricate prototype implant units, and to evaluate these units in acute and chronic animals, to determine the feasibility for implant study in human volunteers. A partially implantable middle ear hearing assisting system was designed by the investigators in collaboration with a medical device manufacturing industry. The design has an external unit that converts the sound into modulated radio frequency signal transmitted to the implant unit which converts the signal into vibration coupled to the ossicular chain for hearing. The significant and unique approaches of the system are: (a). non-contact electromagnetic coupling of vibration from the device to ossicular chain; (b). no bias force on the ossicular chain when the device is idling, by using special air core coil; (c). no battery in the implant unit to limit the life of the device; (d). all electronics and the coil are hermetically encapsulated in Titanium to prevent corrosion and degradation during the life time; all materials in contact with the body are biocompatible and is expected to have indefinite life; and (e). the implant unit is miniaturized and manufacturable with existing fabrication technology. The specific aims of the proposed research are: (a). to characterize the performance of the designed hearing assisting system in laboratories with engineering instruments and test it in experiments on acute animals and human temporal bones. Necessary tools for implant operation will be developed to insure that the implant will have consistent and desired performance; (b). to evaluate the implant device and the total system in acute and chronic animals, to identify any parts that need improvement and to determine the expected life time of the implant device and the total system; (c). to study the physiology of the ossicular chain with acute and chronic animals; (d). to determine the feasibility of the device for human implant and to modify the system for future evaluation on human volunteers.

基于对部分植入中耳获得的研究结果 听力辅助设备，三年的多学科研究是 提出了改进设计的目标，以制造 原型植入单元，并以急性和慢性评估这些单位 动物，确定人类植入物研究的可行性 志愿者。 设计了部分可植入的中耳听力辅助系统 由调查人员与医疗设备制造合作 行业。 该设计的外部单元将声音转换为 调制射频信号传输到植入单元，该信号 将信号转换为振动，耦合到骨链 听力。 系统的重要方法是：（a）。 从设备到振动的非接触电磁耦合 骨链； （b）。当骨链上没有偏置力 通过使用特殊的空气芯线圈，设备空转； （c）。没有电池 植入单元限制设备的寿命； （d）。所有电子和 线圈在钛中被封装在钛中以防止腐蚀 和生命中的退化；所有与之接触的材料 身体是生物相容性的，有望拥有不定的寿命。 （e）。 植入物单位是小型和可制造的 制造技术。 拟议研究的具体目的是：（a）。表征 通过实验室中设计的听力辅助系统的性能 工程仪器并在急性动物的实验中对其进行测试 人类颞骨。 植入物操作的必要工具将是 开发以确保植入物具有一致和期望的 表现; （b）。评估植入设备和总系统 急性和慢性动物，以识别需要改进的任何部分 并确定植入设备的预期寿命和 总系统； （c）。研究骨链的生理学 急性和慢性动物； （d）。确定可行性 人类植入物的设备并修改系统以进行未来评估 关于人类志愿者。