Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsoriotaMotion, Inc.
About this trial
Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cochlear implant candidate in one or two ears per current FDA indications
Sufficient residual hearing to support use of electrocochleography, as determined by the investigator
Cochlear implantation using the Advanced Bionics SlimJ electrode array
18 years of age or older at the time of enrollment
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
iotaSOFT Insertion System with AIM
DeviceExperimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop
iotaSOFT Insertion System with AIM Control
DeviceiotaSOFT Insertion System with AIM using standard of care insertion techniques
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Device Feasibility
Feasibility of device functionality intraoperatively at the time of cochlear implant surgery.
Time frame
Procedure Day 0Sponsors and contacts
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Source ClinicalTrials.gov