Advanced Bionics Voluntary Field Corrective Action

Advanced Bionics has issued a press release saying that it will retrieve the initial version of HiRes Ultra and Ultra 3D cochlear implant devices.  Newer versions of the devices have already been approved by some regulatory agencies, and is available in some markets.  Availability may be limited while the new version is being rolled out.

Less than 0.5% of the original version have been explanted related to lower
impedances and reports of decreased hearing performance. This situation does not present a device related safety issue.