Cochlear implant system - India CDSCO Medical Device Registration

Product Information

Mi 1250 Synchrony 2 Intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing-impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition. The Mil250 SYNCHRONY 2 Cochlear Implant System is also intended to evoke auditory sensations via electrical stimulation of the auditory pathways for individuals with single-sided deafness, which is defined as severe to profound hearing impairment in one ear and normal hearing or mild to moderate hearing impairment in the other ear. Additionally, the Mil250 SYNCHRONY 2 Cochlear Implant System used in combination with the implant variant Mi 1250 SYNCHRONY 2 (Sonata Ti100) FLEX 24. Mi 1250 SYNCHONY 2 (Sonata Ti100) FLEX 20 is intended to evoke auditory sensations via electrical stimulation or via combined electric- acoustic stimulation (Sonata Ti100) of the auditory path-wavs for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only.