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Post-Market Clinical Investigation of the IotaSOFT Insertion System

NCT06664697 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-10-31

No results posted yet for this study

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

Conditions

  • Hearing Loss, Cochlear
  • Cochlear Implantation
  • Hearing Loss, Sensorineural

Interventions

DEVICE

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.

Sponsors & Collaborators

  • iotaMotion, Inc.

    lead INDUSTRY

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2025-10-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06664697 on ClinicalTrials.gov