MRI-compliant cochlear implant cleared in USOctober 10, 2018
HiRes Ultra 3D cochlear implant, produced by Advanced Bionics, has received clearance from the USFDA.
The new magnet design provides alignment with an external magnetic field in any direction. This allows cochlear implant recipients to move freely around in the strong magnetic field of an MRI machine without feeling pain or discomfort, and without restrictions to the orientation of the head. Even for high resolution MRI examinations, there is no need to remove the magnet and no requirement for head bandaging, meaning no hearing downtime for the patient, the company said.
Previously, patients and surgeons had to contend with the strong magnetic field from MRI machines exerting force on the magnet, causing torque and subsequent pain if the magnet remained in situ, even with head bandaging. Therefore, it was common to remove the magnet for high resolution MRI examinations, requiring outpatient surgery and interrupting the patient’s hearing during the healing process.
Advanced Bionics is developing hearing solutions for individuals with severe-to-profound hearing loss who no longer benefit from hearing aids.