|Trade Name||CLARION DEVICE FITTING SOFTWARE (SCLIN)|
|Generic Name||cochlear implant (pediatric)|
||Ear Nose & Throat
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - software|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the modifications to the device fitting software for adults and pediatrics. The device, as modified, will be marketed under the trade name clarion multi-strategy cochlear implant (adult) and (pediatrics) and is indicated to restore a level of auditory sensation to individuals with profound sensorineural deafness via electrical stimulation of the auditory nerve.