Bone Conduction Implant Implant Kit
- UID
- IMP/MD/2019/000150_6fe87c04d7335f8fb9e017895d26ff02_82f6a0d987329d6eebb014516bb0f5fa
- Device class
- Class D
- Brand name
- Sonata Ti100
- License holder
- Med-el India Private Limited
- Approving authority
- CDSCO
- Product information
- The BONEBRIDGE system with the Bone Conduction Implant BCI 602 is intended to treat patients with either conductive or mixed hearing loss or patients suffering from single-sided sensorineural deafness. The BONEBRIDGE with the BCI 602 augments hearing by providing acoustic information to the inner ear via bone conduction. This is achieved by actuating a vibratory transducer, which is implanted in the temporal bone
Bone Conduction Implant Implant Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000150_6fe87c04d7335f8fb9e017895d26ff02_82f6a0d987329d6eebb014516bb0f5fa. 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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