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
This trial does not accept healthy volunteersQualifiers
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 population
A minimum of 50 subjects with sensorineural hearing loss and who have received a cochlear implant using the commercially available iotaSOFT insertion system or are scheduled for unilateral or bilateral cochlear implant surgery will be enrolled, such that a minimum of 50 subjects/ears using iotaSOFT will be attempted
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cochlear Implantation with Robotic-Assisted Insertion System
DeviceThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Retrospective1 intervention
Group B: Prospective1 intervention
Trial outcomes
Primary outcomes
1
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery
Number of Subjects Experiencing a Serious or Related Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery through 1 month post-operative follow-up
Time frame
1 month post-activationSecondary outcomes
1
Number of device deficiencies related to the use of the iotaSOFT Insertion System
Number of reported device deficiencies related to the use of the iotaSOFT Insertion System at the time of cochlear implant surgery
Time frame
1 month post-activationSponsors and contacts
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Source ClinicalTrials.gov