Actively Recruiting
Post-Market Clinical Investigation of the IotaSOFT Insertion System
Led by iotaMotion, Inc. · Updated on 2024-10-31
50
Participants Needed
3
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Post-Market Clinical Investigation of the IotaSOFT Insertion System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Candidates with sensorineural hearing loss who received or will receive unilateral or bilateral cochlear implantation with FDA approved devices (Advanced Bionics HiFocus SlimJ, Cochlear Slim Straight, MED-EL Flex 24 and 28)
- Age 12 years or older at the time of cochlear implant surgery
- Willingness to participate and ability to comply with follow-up visits
You will not qualify if you...
- Prior cochlear implantation in the ear to be implanted
- Ossification or cochlear abnormalities preventing complete electrode insertion or increasing insertion risk
- Craniofacial abnormalities, temporal skull thickness less than 3mm, major cochlear lesions, or malformations
- Deafness caused by acoustic nerve or central auditory pathway lesions
- Diagnosis of auditory neuropathy
- Active middle-ear infection or tympanic membrane perforation with active disease
- Absence of cochlear development
- Additional medical concerns preventing study participation as determined by the investigator
- Unrealistic expectations about the procedure or device
- Inability to read, understand, or speak English for required procedures
- Current or planned participation in another investigational device or drug study
- Classified as vulnerable subjects per FDA regulations 21 CFR Parts 50 and 56
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Indiana University
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
3
Oregon Health and Sciences University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
L
Laura Chenier, AuD
CONTACT
W
Wade Colburn
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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