Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry
Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.
- Product
- AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
- Category
- Medical Device
- Distribution
- Distributed nationwide