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Evaluation of the Automated Integration of a Robotics and ECochG System for Use With Cochlear Implant Surgery

NCT06664710 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-05-01

No results posted yet for this study

Summary

Evaluation of the Automated Integration of a Robotics and ECochG System for Use with Cochlear Implant Surgery

Conditions

  • Hearing Loss, Sensorineural
  • Cochlear Implantation

Interventions

DEVICE

iotaSOFT Insertion System with AIM

Experimental subjects will receive the iotaSOFT Insertion System with AIM using robotic controlled stop

DEVICE

iotaSOFT Insertion System with AIM Control

iotaSOFT Insertion System with AIM using standard of care insertion techniques

Sponsors & Collaborators

  • iotaMotion, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2025-08-30
Completion
2025-08-30
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 NCT06664710 on ClinicalTrials.gov