Advanced Bionics announced a voluntary recall of the initial version of its HiRes Ultra and Ultra 3D cochlear implant devices due to a decrease in performance experienced by some recipients.
The company has experienced recent increases in Ultra device explants related to low impedances and reports of hearing performance degradation. As of Feb. 11, in the cases that have been explanted, fluid ingress at the electrode has occurred, leading to interruption of stimulation. Less than 0.5% of the 16,000 recipients of the implants were explanted for that reason. The only potential for patient harm comes with the risks associated with the required revision surgery if the issue arises, according to a news release.
Existing recipients of HiRes Ultra and Ultra 3D can continue using their devices as normal, but if they experience hearing degradation issues, they’re urged to visit their audiologist or another healthcare provider. AB also said it plans to begin its notification process for device recipients worldwide to make them aware when allowed.
AB said it developed several improvements, including a new version of the device, to address the issue, and it received regulatory approval in the U.S. and in Europe for those improvements. It plans to submit the improvements to additional regulatory agencies around the world.
AB said it will continue to distribute the HiRes 90K Advantage cochlear implant, along with the new versions of the Ultra and Ultra 3D implants, based on market availability. Previous generations of AB cochlear implants and external sound processors and accessories are not included in the scope of AB’s recall.
