iotaSOFT Pediatric Study

Inclusion Criteria:

• Candidate for unilateral or bilateral cochlear implantation according to indicationsfor 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 visitrequirements

Exclusion Criteria:

• Prior cochlear implantation in the ear to be implanted

• Ossification or any other cochlear anomaly that might prevent complete insertion ofthe electrode array or present an increased risk of aberrant insertion

• Craniofacial abnormality, temporal squamosal skull thickness less than 3mm, majorcochlear 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 ofactive middle-ear disease

• Absence of cochlear development

• Additional medical concerns that would prevent participation in evaluations asdetermined by the investigator

• Planned or current participation in a clinical study of an investigational device ordrug