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Post-Market Clinical Investigation of the IotaSOFT Insertion System
Sponsor: iotaMotion, Inc.
Summary
The purpose of the proposed study is to evaluate the continued safety of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a CI electrode array in one ear per subject
Official title: Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
OBSERVATIONAL
Enrollment
50
Start Date
2024-10-01
Completion Date
2025-12-31
Last Updated
2024-10-31
Healthy Volunteers
No
Interventions
Cochlear Implantation with Robotic-Assisted Insertion System
The purpose of the study is to collect additional safety data in retrospective and prospective subjects who receive a cochlear implant using the iotaSOFT Insertion System.
Locations (3)
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Oregon Health and Sciences University
Portland, Oregon, United States