This document is a surgical guideline for the MED-EL CONCERTO/CONCERTO PIN Auditory Brainstem Implant System. It introduces how to implant the system correctly.
This document serves as a surgical guideline for the implantation of the MED-EL CONCERTO/CONCERTO PIN Auditory Brainstem Implant (ABI) system, specifically the Mi1000 model. It is intended for use by experienced neuro- and ENT-surgeons and describes proper techniques for implanting the device in patients with non-functional cochlear nerves, such as those caused by trauma, inflammation, or Neurofibromatosis Type 2 (NF2). The system is designed to restore some sense of hearing via electrical stimulation of the cochlear nucleus (CN).
| Maximum current amplitude | 1250 µA |
|---|---|
| Maximum pulse width | 203.8 µs |
| Impedance measurement accuracy | better than 5 % |
| MRI safe field strengths | 0.2 Tesla, 1.0 Tesla and 1.5 Tesla |
| Number of independent current sources | 24 |
| Number of independent electrode channels | 12 |
| Implant mass | 7.6 g |
| Implant volume without electrode | 3.7 cm³ |
| Stimulation rate capability | 50,704 pulses per second |
It is used for electrical stimulation of the cochlear nucleus (CN) in patients with non-functional cochlear nerves.
The device is intended to be implanted by adequately trained and experienced surgeons only.
No, the implant contains no batteries or other components that require replacement.
The materials in direct contact with human tissue are medical grade silicone, platinum, and iridium.