Cochlear Recall Issued for Nucleus CI500 Ear Implant

Cochlear Limited has announced a worldwide recall for its Nucleus CI500-series ear implants, after receiving an increasing number of reported failures. 

The manufacturer of the popular cochlear ear implants issued a press release announcing the Nucleus CI500 cochlear ear implant recall, indicating that less than 1% of the CI512 implants had failed since the devices were put on the market in 2009. However, a recent increase in failure reports has led the company to recall the devices and launch an investigation. The press release does not say how many devices have failed or how many have been implanted in patients around the world.

Company officials have said the devices are shutting down unexpectedly, but they do not know the cause of the problem. They also indicated that the recalled Cochlear implants are unlikely to cause problems for recipients beyond the bionic ear failing.

The Cochlear recall affects all Nucleus CI500-series cochlear implants. However, individuals who already have the implant can continue to use their system as normal. If the implant fails, the company says it will safely shut down and recipients can be re-implanted with the Nucleus Freedom cochlear implant, which is not affected by the recall.

A cochlear implant, or bionic ear, is an electrionic device that is surgically implanted to provide a senses of sound for individuals who are profoundly deaf or hard of hearing.

Last November, Advanced Bionics recalled some of the HiRes 90k cochlear implants due to defects that could cause pain and loud noises for recipients. There were at least two confirmed cases where patients experienced malfunctions that resulted in severe pain, overly loud sounds and shocking sensations less than two weeks after receiving the implants.

Photo via Wikimedia Commons, public domain work of the National Institutes of Health