FDA clears HiRes Ultra 3D Cochlear
Implant for use in fMR procedures

FDA clears hearing implant as safe for high-resolution MR scans

September 04, 2018
by John R. Fischer, Senior Reporter
Removing magnets during high-resolution MR procedures for patients with hearing implants may be in the past, following the FDA’s clearance of the HiRes Ultra 3D Cochlear Implant designed by Advanced Bionics, a subsidiary of the Sonova Group.

Built on the HiRes Ultra platform, the implant enables recipients to move freely around strong magnetic MR fields without feeling pain or discomfort due to its magnetic design, capable of providing alignment with an external magnetic field in any direction.

“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,” Hansjuerg Emch, group vice president of cochlear implants (CI) at Sonova, said in a statement. “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.”

The presence of strong magnetic fields from MR systems initially exerted force on the magnet, causing torque and subsequent pain if the magnet remained in situ, even when bandaging was applied to the patient’s head. Avoiding this outcome often involved removing the magnet for high-resolution MR exams, leading to outpatient surgery and disruptions to the patient’s hearing while they healed.

The HiRes Ultra 3D Cochlear Implant is designed to undergo heavy usage of MR procedures without the loss of magnetic strength or mobility of the magnet components. It also eliminates the need to apply head bandaging which, along with not having to remove the magnet, avoids the onset of hearing downtime for patients.

Its clearance follows that of another implant, Envoy Medical Corporation’s Esteem Hearing Implant. It is the first and only active middle ear implant cleared by the FDA for MR-conditional labeling, and can be used with both 1.5 and 3 Tesla scanners.

“MR compatibility is an important consideration when thinking about any implanted hearing solution,” Dr. Jack Shohet of Shohet Ear Associates Medical Group in Orange County, California, said in a statement. “The news about the Esteem – that we now have a middle ear implant that can be safely scanned at both 1.5 and 3.0 Tesla – represents a significant advancement in middle ear implant technology and its applicability to a broader group of patients.”