iotaMotion, Inc.
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.
Inclusion Criteria: 1. Cochlear implant candidate in one or two ears per current FDA indications 2. Sufficient residual hearing to support use of electrocochleography, as determined by the investigator 3. Cochlear implantation using the Advanced Bionics SlimJ electrode array 4. 18 years of age or older at the time of enrollment 5. Willingness to participate in and comply with all requirements of the protocol Exclusion Criteria: Contraindications for a CI. 2. Prior cochlear implantation in the ear to be implanted. 3. Cochlear ossification or malformation (including but not limited to dysplas…
Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
iotaSOFT Insertion System with AIM using standard of care insertion techniques
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