iotaSOFT Pediatric Study

Not Applicable

Recruiting

• Conditions: Hearing Loss, Unilateral; Hearing Loss, Bilateral; Hearing Loss, Sensorineural
• Interventions: Device: iotaSOFT Insertion System

• Registration Number: NCT06106373
• Lead Sponsor: iotaMotion, Inc.

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 pediatric population.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-17
• Study First Submitted: 2023-10-24
• Study First Submitted QC: 2023-10-24
• Study First Posted: 2023-10-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pediatric Cochlear Implant Recipient	iotaSOFT Insertion System	Pediatric subjects receiving a cochlear implant between the ages of 9 months and under 12 years of age.

Primary Outcome Measures

Name	Time	Method
Safety related to adverse events	30 days following surgery	Evaluation of iotaSOFT related adverse events and serious adverse events through 30 days after surgery

Trial Locations

Locations (2)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Texas Childrens Hospital; 🇺🇸 Houston, Texas, United States