Overview
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.
Eligibility
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