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障碍 没有有效的治疗，除了康复策略，不能恢复正常的前庭-眼睛或前庭-脊髓反射。由于人工耳蜗术的巨大成功，人们一直在努力为患病的前庭系统开发类似的神经假体。我们已经开发了一种前庭神经刺激器，在恒河猴身上进行了研究，并在FDA的研究设备豁免下进行了四次人类植入，用于治疗失控的梅尼埃病。我们的四名人类受试者在手术后听力严重丧失，所有人类受试者和我们的一些猴子在手术后几个月都观察到电诱发反应的显著丧失。我们建议对我们现有的装置进行改进，以在迷路内提供更大的稳定性，并部分恢复植入耳的听力。我们还提出了一系列详细的纵向人体研究，以表征我们为治疗前庭损失而开发的陀螺仪传感器的功能，以及在非人类灵长类动物中进行新设计的安全性研究。这些研究将极大地提高我们对前庭植入物在人类中的影响的了解，并使我们能够开发一种用于治疗单侧和双侧无补偿前庭缺失的研究装置豁免。

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.