Cochlear Implant Made by Advance Bionics RecalledNov 24, 2010 | Parker Waichman LLP
The HiRes 90K cochlear implant is being recalled by Advanced Bionics, the US unit of Sonova Holding AG. The cochlear implant recall is being issued after two patients with the HiRes 90K device suffered from severe pain and overly loud sounds about eight to 10 days after its implantation.
A Cochlear implant is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly deaf or severely hard of hearing. Unlike hearing aids, the cochlear implant does not amplify sound, but works by directly stimulating any functioning auditory nerves inside the cochlea with electrical impulses. External components of the cochlear implant include a microphone, speech processor and transmitter.
According to The Wall Street Journal, about 28,000 HiRes 90K devices have been installed since the product was launched about five years ago. A Sonova spokesman told the journal “about 1,000 patients” have received the implant over the past 14 days and that some of them could be at risk to suffer from complications, but declined to give an estimate.
Sonova said it would pay for the removal of the cochlear implant in any other patients who suffer side effects.
This is not the first time Advance Bionics has recalled this device. In 2004, the company recalled all unimplanted Clarion 1.2, Clarion II / CII and HiRes90k cochlear implants. The company began shipping these devices again in November 2004, but a second recall was issued in March 2006
In 2007, the US Food & Drug Administration (FDA) filed a civil action against Advanced Bionics alleging that the company sold and manufactured adulterated cochlear implants. Advanced Bionics settled that suit paying $1.1 Million Dollars on behalf of the company, and $75,000 on behalf of then CEO Jeff Greiner.
As with most implanted medical devices, there is a risk of some serious side effects when using cochlear implants. These may include:
• Total loss of natural hearing due to damaged cochlea cells (This damage can occur during implantation of this device.)
• Bacterial meningitis, a life-threatening inflammation of the brain and/or spinal cord
• Tissue death in the skin surrounding cochlear implants
In 2007, the FDA warned that children with cochlear implants faced a higher risk for developing bacterial meningitis, a potentially deadly infection, and must be fully immunized against the disease. The warning came after two children with the devices died due to bacterial meningitis.
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