iotaSOFT Pediatric Study

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