Cochlear has been forced to recall all the units of its Nucleus CI500 hearing implants after a growing number of them shut down and stopped working.
Sydney-based Cochlear says there has been a rise in the number of faults reported against the CI512 model in recent weeks. While these faults are unlikely to cause health problems to customers with the defective implants, they are offering replacement models for re-implantation.
The replacements are Nucleus Freedom models, a previous generation of implants.
Cochlear was unable to explain the fault with the titanium-based implants, and is currently evaluating the situation. It has halted manufacturing of the CI500’s until the cause has been determined. However, the firm will likely need to go through the long process of regulatory approvals for the units again.
The company has encouraged people with functional units to continue using them, but has undertaken a voluntary recall of the CI512, CI513, CI551 double array implant and ABI 541 auditory brainstem implant.
Cochlear designs, manufactures and sells the Nucleus Cochlear implant and the BAHA osseointegrated bone conduction implant.