NCT07081542 - Comparative Analysis of Hearing Outcomes: Robotic vs. Manual Insertion of Cochlear Implants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 30, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2027

Conditions

Sensorineural Hearing LossBilateral Hearing LossCochlear ImplantationHearing DisordersHearing Disorders and DeafnessInner Ear DisordersHearing Impairment

Interventions

DEVICE

IotaSoft Robotic Insertion System

The IotaSoft robotic insertion device is an FDA-approved tool designed to provide precise and controlled insertion of the cochlear implant electrode array to minimize trauma during implantation.

PROCEDURE

Manual Cochlear Implant Insertion

Standard surgical technique for manually inserting the cochlear implant electrode array. This method reflects the current standard of care without the assistance of robotic tools.

Trial Locations (1)

34747

AdventHealth Celebration, Kissimmee