Post-Market Clinical Investigation of the IotaSOFT Insertion System
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsoriotaMotion, Inc.
About this trial
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
Eligibility criteria
Qualifiers
Advanced Bionics HiFocus SlimJ
Cochlear Slim Straight
MED-EL Flex 24 and 28
Age 12 years or older at the time of CI surgery.
Disqualifiers
Prior cochlear implantation in the ear to be implanted.
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion.
Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions (e.g., fibrosis, fracture, or ossification), or cochlear malformations.
Deafness due to lesions of the acoustic nerve or central auditory pathway.
Trial design
Treatments tested in this trial
- Cochlear Implantation with Robotic-Assisted Insertion System
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov