Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Observational
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:
‣ Advanced Bionics HiFocus SlimJ
⁃ Cochlear Slim Straight
⁃ MED-EL Flex 24 and 28
• Age 12 years or older at the time of CI surgery.
• Willingness to participate in the study and able to comply with the follow-up visit requirements.
Locations
United States
Iowa
University of Iowa
NOT_YET_RECRUITING
Iowa City
Indiana
Indiana University
RECRUITING
Indianapolis
Oregon
Oregon Health and Sciences University
RECRUITING
Portland
Contact Information
Primary
Laura Chenier, AuD
lchenier@iotamotion.com
442-325-4171
Backup
Wade Colburn
wcolburn@iotamotion.com
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 50
Treatments
Retrospective
Retrospective Review of patient records
Prospective
Prospective data collection of subjects receiving a cochlear implant with robotic-assisted cochlear implant
Related Therapeutic Areas
Sponsors
Leads: iotaMotion, Inc.