NCT06664710

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: iotaMotion, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

The purpose of this study is to evaluate the feasibility and proof of concept of the integration of the AIM System and iotaSOFT Insertion System during cochlear implantation. Study results will help inform the need for future clinical investigations and data collection in the area of ECochG and robotic-assisted cochlear implantation.

Conditions

• Hearing Loss, Sensorineural
• Cochlear Implantation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-01-17
• Primary completion: 2025-08-30
• Completion: 2025-08-30
• First posted: 2024-10-29
• Last updated: 2025-05-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study