An observational study in Hearing Loss, Cochlear, Cochlear Implantation and Hearing Loss, Sensorineural, sponsored by iotaMotion, Inc.. Recruiting at 3 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by iotaMotion, Inc. · Observational
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.
1,092 studies on the registry are indexed under Hearing Loss; 235 are open to participants now.
This study's planned enrollment of 50 is below the median of 87 across 270 observational studies indexed under Hearing Loss.
Browse Hearing Loss studies →iotaMotion, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices, as listed below:
Exclusion Criteria:
Retrospective Review of patient records
Device: Cochlear Implantation with Robotic-Assisted Insertion System
Prospective data collection of subjects receiving a cochlear implant with robotic-assisted cochlear implant
Device: Cochlear Implantation with Robotic-Assisted Insertion System
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.
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-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
Plan to share: Yes — Cohort data will be provided for analysis for publication and presentation and individual data points will be pulled for reporting requirements only. Primary and secondary endpoint data will be exported and analyzed for required reporting.
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
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iotaMotion, Inc.