Cochlear nucleus CI500 implant range
Recall of un-implanted Cochlear Nucleus CI500 Implant Range
The Therapeutic Goods Administration (TGA) advises that un-implanted products in the Cochlear Nucleus CI500 Implant Range are being recalled.
There are no safety concerns for patients implanted with devices from the Cochlear Nucleus CI500 Implant Range.
The products being recalled are:
- CI512 cochlear implant with contour advance electrode (Part Number :Z209051), Australian Register of Therapeutic Goods (ARTG) 165361
- CI513 cochlear implant with contour advance electrode (Part Number: Z110048), ARTG 165362
- ABI541 Auditory Brainstem Implant (Part Number: Z246604), (Available via Special Access Scheme only)
- CI551 Double Array (Part Number: Z246605) (Available via Special Access Scheme only)
This recall follows a recent increase in the number of failures. The information currently available to the TGA is that less than 1% of these implants have failed. The root cause of the problem is under investigation.
No Cochlear implants outside of the Nucleus CI500 implant range are affected. Unaffected products include the Nucleus Freedom range (CI24RE CA, CI24RE ST), the Hybrid L24 electrode, the Nucleus CI422 slim straight electrode, the CI24 R CA, CI24 R ST, CI24 R CS, the Nucleus 24M double array and the Nucleus ABI 24M.
Cochlear will be sending recall letters to the implanting hospitals/surgeons commencing 14 September 2011.
Information for patients
- If patients notice that their implant has ceased to function they should contact their medical practitioner, audiologist or hearing clinic.
Information for health professionals
- The TGA is working with Cochlear Ltd to ensure that appropriate information is made available to clinicians while the issues are further investigated.
- The Cochlear Nucleus CI512/CI513 implants have been on the Australian market since September 2009.
This device works by picking up sound through a microphone outside the body, which feeds the signals through a speech processor and then to a radio transmitter, which sends the information to an implant inside the patient’s head. The receiver/stimulator section of the implant placed inside the mastoid portion of the temporal bone sends the signals through an electrode array into the nerves of the cochlea (a small snail shell-shaped structure of the inner ear).