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.
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Source: Mass Device - August 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Otolaryngology Ear, Nose & Throat Regulatory/Compliance Advanced Bionics LLC Sonova Holding AG Source Type: news