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_6e65507ff835b72dd391f32434218eac_d478fc7e630bd1fc62212975c490e6ac. 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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CDSCO Registered

Class Class D

Cochlear implant system

UID: IMP/MD/2019/000150_6e65507ff835b72dd391f32434218eac_d478fc7e630bd1fc62212975c490e6ac

Brand Name

Sonata Ti100

License Holder

Med-el India Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

The Mi1210 Synchrony ST 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 Mil210 SYNCRHONY ST 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 Mi1210 SYNCRHONY ST Cochlear Implant System used in Combination with the implant variant SYNCHRONY ST+ FLEX 24 SYNCHRONY ST+FLEX 20 is intended to evoke auditory sensations via electrical stimulation or via combined electric-acoustic stimulation [EAS] of the auditory path-ways for partially deaf individuals, who obtain benefit from acoustic amplification in the lower frequencies only

Class D

Bone Conduction Implant

Brand: Sonata Ti100

Med-el India Private Limited

Class D

Brand: Sonata Ti100

Class D