🏛️ Verified NIH Record • Updated 2024-10-29
Post-Market Clinical Investigation of the IotaSOFT Insertion System (NCT06664697)
Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
🟢 Recruiting Interventional Protocol 📊 Observational Clinical Research Sponsor: iotaMotion, Inc.
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Indiana University — Indianapolis, Indiana
Age range: 12 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Indiana University — Indianapolis, Indiana
- University of Iowa — Iowa City, Iowa
- Oregon Health and Sciences University — Portland, Oregon
📞 Contact the Study Coordinator
Phone: (442) 325-4171
Email: lchenier@iotamotion.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.