iotaSOFT Pediatric Study

iotaSOFT Insertion System for Use With Cochlear Implant Surgery in Pediatrics

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.

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