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Summary
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pediatric population.
Official title: iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics
Key Details
Gender
All
Age Range
9 Months - 12 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-05-17
Completion Date
2025-07-10
Last Updated
2026-08-06
Healthy Volunteers
Yes
Interventions
DEVICE
iotaSOFT Insertion System
robotic assistive technology for cochlear implant electrode insertion
Locations (2)
University of Iowa
Iowa City, Iowa, United States
Texas Childrens Hospital
Houston, Texas, United States