Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant

Sonova Holding AG (SIX:SOON) subsidiary Advanced Bionics said yesterday that it won FDA approval for its HiRes Ultra 3D cochlear implant.

The newly approved implant is cleared for use during magnetic resonance imaging examinations as it features a new magnet design which provides alignment with an external magnetic field in any direction.

The magnet allows users to move freely around an MRI machine’s magnetic field without pain or discomfort, or the need for removal or head bandaging, Advanced Bionics said.

“After many years of research and development, the new magnet technology in our cochlear implants will improve the quality of life for our many recipients due to our hassle free and pain free magnet. We are leading the way and ensuring our recipients have the best possible experiences with our advanced technology. It’s a powerful innovation and makes our efforts so rewarding for patients,” Sonova cochlear implants group VP Hansjuerg Emch said in a press release.

Last December, Advanced Bionics said that it plans to integrate Sonova‘s Sword chip and wireless radio tech into its sound processors.

The post Advanced Bionics wins FDA nod for MRI-safe HiRes Ultra 3D cochlear implant appeared first on MassDevice.

Advanced Bionics wins FDA nod for HiFocus Slimj cochlear implant electrode

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Advanced Bionics

Advanced Bionics said late last week it won FDA approval for its HiFocus SlimJ electrode designed for use with the company’s HiRes Ultra cochlear implant.

The Valencia, Calif.-based company touts the new electrode as featuring a thin, straight design for easier insertion during procedures and a slim profile to protect the delicate structures of the cochlea during insertion.

“The HiFocus SlimJ electrode addresses the surgeon need for an alternate type of electrode whilst still offering full spectrum coverage and maintaining the performance potential of the individual. And surgeons have commented that it is easy to handle and to insert,” Advanced Bionics medical marketing & product management director Mark Downing said in a prepared statement.

Advanced Bionics said the addition of the new electrode along with its HiFocus Mid-Scala electrode provides surgeons with personalized choices during procedures to accomodate individual patient anatomy and surgical preferences.

“I am very pleased with the successful implantations in Europe following the TÜV approval. This marks an important milestone not only for Advanced Bionics but for all future CI candidates,” Sonova cochlear implants group VP Hansjuerg Emch said in a press release.

Last November, a federal appeals court overturned a win for Cochlear Ltd. (ASX:COH) in its patent spat with Advanced Bionics over hearing implant technology, sending the case back to district court for reconsideration in light of a recent U.S. Supreme Court decision.