Department of Otolaryngology-Head and Neck Surgery, The University of Iowa Carver College of Medicine.
iotaMotion Inc., Iowa City, Iowa.
Otol Neurotol. 2023 Jan 1;44(1):34-39. doi: 10.1097/MAO.0000000000003749. Epub 2022 Nov 14.
To evaluate the safety and utility of an investigational robotic-assisted cochlear implant insertion system.
Prospective, single-arm, open-label study under abbreviated Investigational Device Exemption requirements.
All procedures were performed, and all data were collected, at a single tertiary referral center.
Twenty-one postlingually deafened adult subjects that met Food and Drug Administration indication criteria for cochlear implantation.
All patients underwent standard-of-care surgery for unilateral cochlear implantation with the addition of a single-use robotic-assisted insertion device during cochlear electrode insertion.
Successful insertion of cochlear implant electrode array, electrode array insertion time, postoperative implant function.
Successful robotic-assisted insertion of lateral wall cochlear implant electrode arrays was achieved in 20 (95.2%) of 21 patients. One insertion was unable to be achieved by either robotic-assisted or manual insertion methods, and the patient was retrospectively found to have a preexisting cochlear fracture. Mean intracochlear electrode array insertion time was 3 minutes 15 seconds. All implants with successful robotic-assisted electrode array insertion (n = 20) had normal impedance and neural response telemetry measures for up to 6 months after surgery.
Here we report the first human trial of a single-use robotic-assisted surgical device for cochlear implant electrode array insertion. This device successfully and safely inserted lateral wall cochlear implant electrode arrays from the three device manufacturers with devices approved but he Food and Drug Administration.
评估一种研究性的机器人辅助人工耳蜗植入系统的安全性和实用性。
根据简化的研究性器械豁免要求进行的前瞻性、单臂、开放性研究。
所有程序均在一个单一的三级转诊中心进行，所有数据均在此收集。
21 名后天失聪的成年患者，符合人工耳蜗植入的食品和药物管理局（FDA）适应证标准。
所有患者均接受了单侧人工耳蜗植入的标准护理手术，并在耳蜗电极插入过程中添加了一次性使用的机器人辅助插入装置。
人工耳蜗电极阵列的成功插入、电极阵列插入时间、术后植入物功能。
在 21 名患者中，有 20 名（95.2%）成功地进行了机器人辅助的外侧壁人工耳蜗电极阵列插入。有 1 例无法通过机器人辅助或手动插入方法实现，且患者被追溯发现存在预先存在的耳蜗骨折。平均内置耳蜗电极阵列插入时间为 3 分 15 秒。所有成功进行机器人辅助电极阵列插入的植入物（n=20）在术后 6 个月内均具有正常的阻抗和神经反应遥测测量值。
在这里，我们报告了首例使用一次性机器人辅助手术设备进行人工耳蜗电极阵列插入的人体试验。该设备成功且安全地插入了来自 3 家设备制造商的外侧壁人工耳蜗电极阵列，这些设备均已获得 FDA 批准。
