What cochlear implants are affected by this recall?
The Advanced Bionics HiResolution 90k (HiRes 90k) bionic ear system with a feedthru component supllied by Supplier B, also known as Astro Seal, Inc. Advanced Bionics has chosen not to recall devices that have been implanted into patients. In other words, if you are currently inplanted with vendor B device, please remain aware of this situation and contact your health care provider and/or audiologor for help.
Why is this recall taking place?
Advanced Bionics voluntarily recalled certain HiRes90k cochlear implants containing the vendor B feedthru component manufactured from Astro Seal, Inc. that have NOT been implanted because of an elevated risk of device failure because of moisture-related issues. Advanced Bionics removed unimplanted devices from hospital inventory.
Will any upcoming cochlear implant surgery be affected by the recall?
No, as the recall affected only unimplanted HiRes 90k cochlear implants. At the time of the recall, Advanced Bionics assuired that all HiRes90K devices manufactured with the particular component from Supplier B were removed from hospital inventory and have shipped only devices that had been manufactured by Supplier A
What are the symptoms of a moisture related device failure?
As reported by Advanced Bionics, “The predominant symptom for implants that experience a moisture-related malfunction is loss of lock (inability for the internal implant to accept communication from the external headpiece) resulting in no sound perception. This is commonly preceded by a period of intermittency (sound going on and off), or the perception of an overly loud sound. There are other potential reasons for these types of symptoms, including external equipment malfunction (processor, microphone, headpiece, cable); therefore, we recommend that you follow routine troubleshooting procedures and if concerns remain, please consult your implant center.”
Does the recall affect patients with no symptoms?
Per Advanced Bionics, if a patient has no symptoms, the recall does not affect the patient, and no action is required on the patient’s part.
