NCT06664697

Post-Market Clinical Investigation of the IotaSOFT Insertion System

Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: iotaMotion, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

Detailed description

available iotaSOFT Insertion System when used per intended use for insertion of a cochlear implant electrode array in subjects 12 years and older. The purpose of the study is to collect additional safety data in retrospective and prospective subjects. The primary object of the study is to demonstrate post-market safe use of the commercially available iotaSOFT Insertion System. The secondary objective of the study is to define procedural characteristics including device deficiencies, electrode array insertion speed, rate of tip fold-over, and objective measures of cochlear implant functionality to demonstrate effective use of the commercially available iotaSOFT Insertion System.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-10-31
• Completion: 2025-12-31
• First posted: 2024-10-29
• Last updated: 2024-10-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study