Cochlear Ltd., a world leader in advanced hearing loss solutions, announced that it is undertaking a voluntary recall of the unimplanted Nucleus CI500 cochlear implant range due to implant failures.

Cochlear said in a statement that it has already started notifying healthcare professionals and regulatory authorities.

While less than 1% of CI512 implants have failed since launch in 2009, Cochlear has identified a recent increase in the number of Nucleus CI512 implant failures.

"In an abundance of caution Cochlear has issued a voluntary recall of the Nucleus CI500 range of cochlear implants while it further investigates the cause of this issue," the company said.

Cochlear assured that if failure occurs the implant safely shuts down without injuring the recipient.

It said that in the event of a Nucleus CI512 series implant failure recipients may be re-implanted with the Nucleus Freedom implant range which remains available.

"All existing recipients with a Nucleus CI500 series implant can continue to use their system as normal," the company said.

The Nucleus CI500 implant range includes the Nucleus CI512 implant plus the following implants which are only available in limited markets – Nucleus CI513, Nucleus CI551 double array implant and Nucleus ABI 541 Auditory Brainstem Implant.

"This voluntary recall does not affect any previous implant models including the Nucleus Freedom implant range which continues to be available," it said.

Cochlear added that the Nucleus 5 external devices (for example, Nucleus CP810) and any previous generation externals
are not subject to this recall.

"Our current priority is to ensure all cochlear implant healthcare professionals and recipients have the necessary information and support required," it said.

"Cochlear takes reliability extremely seriously and all necessary measures are being implemented to address this unexpected occurrence. The financial impact of this recall is difficult to predict at this stage," the company added.