iotaSOFT Pediatric Study
Completed · Not applicable
Conditions studied: Hearing Loss, Sensorineural, Hearing Loss, Bilateral, Hearing Loss, Unilateral
In brief
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 pediatric population.
Key facts
- Study ID
- NCT06106373
- Run by
- iotaMotion, Inc.
- People needed
- 20
- Starts
- 2022-05-17
- Expected to finish
- 2025-07-10
- Last updated by the study team
- 2026-08-06
Who can join
Age: 1 and older, up to 12. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Iowa — Iowa City, Iowa, United States
- Texas Childrens Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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