Optimization of a human vestibular prosthesis

描述（由申请人提供）：前庭疾病会造成生产力和生活质量的巨大损失。双侧前庭功能丧失目前是一种疾病 除了康复策略之外，如果没有有效的治疗，就无法恢复正常的前庭眼反射或前庭脊髓反射。由于人工耳蜗植入的巨大成功，人们付出了巨大的努力来为患病的前庭系统开发类似的神经假体。我们开发了一种前庭神经刺激器，在恒河猴身上进行了研究，并根据 FDA 研究设备豁免进行了四次人体植入，用于治疗不受控制的梅尼埃病。我们的四名人类受试者术后出现了严重的听力损失，并且在术后几个月内，我们所有的人类受试者和一些猴子都观察到电诱发反应的显着丧失。我们建议对现有设备进行修改，以在迷路内提供更大的稳定性，并部分恢复植入耳朵的听力。我们还提出了一系列详细的纵向人体研究，采用新设计来表征我们为治疗前庭丧失而开发的陀螺仪传感器的功能，以及新设计在非人类灵长类动物中的安全性研究。这些研究将极大地增强我们对前庭植入物对人类影响的理解，并使我们能够开发一种研究性设备豁免，用于治疗无代偿的单侧和双侧前庭丧失。

DESCRIPTION (provided by applicant): Vestibular disorders exact a huge toll in lost productivity and quality of life. The bilateral loss of vestibular function is currently a disorder without effective treatment other than rehabilitative strategies which cannot restore normal vestibulo-ocular or vestibulo-spinal reflexes. Due to the extraordinary success of cochlear implants, there has been a major effort to develop a similar neural prosthesis for the diseased vestibular system. We have developed a vestibular neurostimulator, studied it in rhesus monkeys, and performed four human implants under an FDA investigational device exemption for the treatment of uncontrolled Meniere's disease. Our four human subjects have had profound hearing loss postoperatively and significant loss of electrically-evoked responses has been observed in all of our human subjects and some of our monkeys over months postoperatively. We propose a modification to our existing devices to provide greater stability within the labyrinth and to partly restore hearing in the implanted ear. We also propose a detailed series of longitudinal human studies with the new design to characterize the function of a gyroscopic sensor that we have developed for the treatment of vestibular loss as well as safety studies of the new design in non-human primates. These studies will greatly enhance our understanding of the effects of a vestibular implant in humans and allow us to develop an investigational device exemption for the treatment of uncompensated unilateral and bilateral vestibular loss.