Cochlear Implant System - India CDSCO Medical Device Registration
Cochlear Implant System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000150_e1a2e1d7a97171f5e4f09eb4e8772e11_4121268b6407e16c7d013b07a9f4bc2d. This device is marketed under the brand name Sonata Ti100. The license holder is Med-el India Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Sonata Ti100
License Holder
Med-el India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The Mi 1050 CONCERTO 2 Cochlear Implant System is 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 Mil050 CONCERTO 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 Mi1050 CONCERTO 2 Cochlear Implant System used in combination with the implant variant Mi1050 CONCERTO 2 FLEX24/ Mi1050 CONCERTO 2 FLEX20 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation (Sonata Ti100) of the auditory path-ways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only
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