A recent recall of Cochlear bionic ear implants will likely cost the manufacturer up to $150 million, as its best selling product, the Nucleus 5 hearing implant, will be off the market for at least six months.
A Cochlear bionic ear recall was issued last month for the entire Nucleus 5 implant series, after an increasing number of customers complained about implant failures. In the interim, Cochlear is trying to convince all of its customers to switch to an older Cochlear implant model, the C124RE implant.
Cochlear launched an investigation into the cause of the problem and have discovered failures in one or more diodes are being caused by moisture entering the implant through a defective seal. This disrupts the transfer of information and power from the sound processor, causing the ear implant to shut down.
Once a full investigation of the problem is complete, the company will need to run clinical tests and get the FDA to approve the implant again before it can be returned to the market. The FDA approval process alone could take as long as 180 days. Therefore, Cochlear officials have indicated that the Nucleus 5 bionic ear will be off the market for six months or longer.
A cochlear implant, or bionic ear, is an electrionic device that is surgically implanted to provide a sense of sound for individuals who are profoundly deaf or hard of hearing.
Photo via Wikimedia Commons, public domain work of the National Institutes of Health