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Study of Robotic and Electrocochleography System Integration for Cochlear Implant Surgery in Adults
Led by iotaMotion, Inc. · Updated on 2025-05-01
10
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the integration of the AIM System with the iotaSOFT Insertion System to assist cochlear implant surgery for patients with sensorineural hearing loss. This study aims to test the feasibility and proof of concept of combining robotic technology and electrocochleography ECochG during cochlear implantation. The results will guide future clinical studies and data collection in this area. Participants will undergo cochlear implantation using the Advanced Bionics SlimJ electrode array. Two study groups are included one group will receive the standard of care using the iotaSOFT Insertion System with AIM, and the other group will receive the experimental treatment using the iotaSOFT Insertion System with AIM controlled robotically. The study is non-randomized and does not involve masking or blinding. During the procedure day Day 0, researchers will assess device feasibility. Participants must comply with all protocol requirements and will be monitored for any medical concerns that could affect participation. The study involves patients 18 years and older who are candidates for cochlear implantation and have sufficient residual hearing to support ECochG.
CONDITIONS
Brief Title
Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Research Team
L
Laura Chenier, Director of Clinical Affairs, AuD
C
Costa Nikou
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