Advanced Bionics receives CE Mark approval for Cochlear Implants

HiRes 90K and HiRes 90K advantage cochlear implants allow 1.5T MRI scans with the CI magnet in place

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This additional compatibility for MRI scans while the CI magnet remains in place helps simplify the diagnostic process

Advanced Bionics (AB) has announced that the HiRes 90K and HiRes 90K advantage cochlear implants have received CE Mark approval from the European Notified Body, TÜV, to undergo 1.5T MRI scans without removing the internal magnet. Previously, these devices had regulatory approval to undergo MRI scans only if the magnet was removed.

This additional compatibility for MRI scans while the CI magnet remains in place helps simplify the diagnostic process by avoiding additional pre- and post-MRI procedures to remove and then to replace the magnet. "Advanced Bionics prioritises the safety and well-being of patients with our cochlear implants. We are very pleased to offer patients this additional compatibility with MRI diagnostic equipment," said Mr Hansjuerg Emch, group vice-president Medical of the Sonova Group.

Cochlear implants are implanted just beneath the skin, and use magnets to link the internal and external components of the CI system. The internal component of the AB cochlear implant system includes electronics and an electrode array that deliver AB's proprietary current steering technology for hearing that more closely resembles normal hearing.

The newest AB electrode array, the HiFocus Mid-Scala electrode, was designed for optimal placement in the cochlea with low insertion force to protect its delicate structures. The HiFocus Mid-Scala electrode accommodates the latest soft surgery approaches, including round window insertion, to suit surgeon preferences and individual recipient needs. The patented design allows for ideal placement so recipients have the opportunity to hear the most pitches possible for enjoying music and improved speech understanding.

The external component of the AB cochlear implant system includes a sound processor that sends signals via the headpiece to the internal component.

 

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