Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
iotaMotion, Inc.
Age
0–12
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
