The iotaSOFT Insertion System Safety Study

Study Overview
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Brief Summary
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Non-significant risk evaluation of the iotaSOFT Insertion System when used by a surgeon to assist with inserting a cochlear implant electrode array.

Detailed Description
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This is a confirmatory study to assess successful peri-procedural use of the iotaSOFT Insertion System and potential adverse events that may be caused by use of the system during cochlear implant surgery.

Official Title
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The iotaSOFT Insertion System Safety Study

Conditions
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Cochlear Implant

Intervention / Treatment
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* Device: iotaSOFT Insertion System


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Candidate for cochlear implantation per indications Age 18 years or older Key Exclusion Criteria: Prior cochlear implantation in ear to be treated Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode ray Craniofacial abnormality or abnormal cochlear/nerve anatomy on pre-operative CT or MR imaging Deafness due to lesions of the acoustic nerve or central auditory pathway Diagnosis of auditory neuropathy Active middle ear infection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: iotaSOFT Insertion System<br>The iotaSOFT Insertion System is a surgical device that aids the surgeon in implanting cochlear electrode arrays by controlling the speed and distance of implant insertion. All subjects enrolled in the trial will have the iotaSOFT Insertion System used during surgery. | Device: iotaSOFT Insertion System<br>* Enrolled subjects undergoing cochlear implant surgery will have the iotaSOFT Insertion System used by the surgeon to assist with implantation of the implant electrode array during the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System during cochlear implant surgery | Proportion of subjects experiencing a peri-procedural adverse event due to use of the iotaSOFT Insertion System and descriptions of reported adverse events. AEs will be summarized by type and number of subjects experiencing an event. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful surgical use of the iotaSOFT Insertion System during cochlear implant surgery as measured by a surgeon utility questionnaire. The questionnaire will be used to calculate the proportion of subjects in which the device performed as intended. | The questionnaire will collect device handling data on proportion of subjects in which the device performed as intended, device utility, and ease of use. | Day 0 |