Post-Market Clinical Investigation of the IotaSOFT Insertion System for Use with Cochlear Implant Surgery
iotaMotion, Inc.
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
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…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below: 1. Advanced Bionics HiFocus SlimJ 2. Cochlear Slim Straight 3. MED-EL Flex 24 and 28 2. Age 12 years or older at the time of CI surgery. 3. Willingness to participate in the study and able to comply with the follow-up visit requirements. Exclusion Criteria: 1. Prior cochlear implantation in the ear to be implanted. 2. Ossification or any other cochle…
Interventions
- DeviceCochlear 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.
Locations (3)
- Indiana UniversityIndianapolis, Indiana
- University of IowaIowa City, Iowa
- Oregon Health and Sciences UniversityPortland, Oregon