Status:
COMPLETED
iotaSOFT Pediatric Study
Lead Sponsor:
iotaMotion, Inc.
Conditions:
Hearing Loss, Sensorineural
Hearing Loss, Bilateral
Eligibility:
All Genders
9-12 years
Phase:
NA
Brief Summary
Prospective, non-randomized, open-label study to evaluate the safety and efficacy of the iotaSOFT Insertion System when used to assist electrode array insertion during cochlear implant surgery in a pe...
Eligibility Criteria
Inclusion
- Candidate for unilateral or bilateral cochlear implantation according to indications for use with FDA approved cochlear implant devices
- Age 9 months to less than 12 years old at the time of CI surgery
- Willingness to participate in the study and able to comply with the follow-up visit requirements
Exclusion
- Prior cochlear implantation in the ear to be implanted
- Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array or present an increased risk of aberrant insertion
- Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, major cochlear lesions, or cochlear malformations
- Deafness due to lesions of the acoustic nerve or central auditory pathway
- Diagnosis of auditory neuropathy.
- Active middle-ear infection or tympanic membrane perforation in the presence of active middle-ear disease
- Absence of cochlear development
- Additional medical concerns that would prevent participation in evaluations as determined by the investigator
- Planned or current participation in a clinical study of an investigational device or drug
Key Trial Info
Start Date :
May 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06106373
Start Date
May 17 2022
End Date
July 10 2025
Last Update
September 15 2025
Active Locations (2)
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1
University of Iowa
Iowa City, Iowa, United States, 52242
2
Texas Childrens Hospital
Houston, Texas, United States, 77030