The iotaSOFT Insertion System Safety Study

iotaMotion, Inc.25 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cochlear Implant

Interventions

iotaSOFT Insertion SystemDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Number of Subjects Experiencing a Peri-procedural Adverse Event Due to Use of the iotaSOFT Insertion System During Cochlear Implant Surgery

Number 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.

Time frame: Day 0

Secondary Outcomes

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.

Time frame: Day 0

Data from ClinicalTrials.gov

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