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
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 to demonstrate effective use of the commercially available iotaSOFT Insertion System.
Study Type
OBSERVATIONAL
Enrollment
50
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.
Indiana University
Indianapolis, Indiana, United States
RECRUITINGUniversity of Iowa
Iowa City, Iowa, United States
NOT_YET_RECRUITINGOregon Health and Sciences University
Portland, Oregon, United States
RECRUITINGNumber 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-activation
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-activation
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