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Cochlear Implants

Cochlear Implants Side Effects Lawsuits | Side Effects: Bacterial Meningitis, Infections, High Fever, Stiff Neck, Fatality | Defective Medical Device, Faulty Rubber Wedge

Cochlear Implants Side Effects May Lead To Bacterial Meningitis Lawsuits

Cochlear Implants | Lawsuits, Lawyers | Side Effects: Bacterial Meningitis, Infections, High Fever, Stiff Neck, Fatality | Defective Device, Faulty Rubber Wedge

On February 6, 2006, the FDA cautioned that children with an early version of the cochlear implant face an increased threat of bacterial meningitis beyond just the first two years following implantation of the hearing devices. This newly announced risk means that young implant patients must be monitored the entire time the implants are in place because infection of the fluid surrounding the brain and spinal cord can occur.  This infection is sometimes fatal.

A Cochlear implant is an electronic hearing device that works by electrically stimulating nerves inside the inner ear.  It is designed to produce useful hearing sensations to children and adults with severe to profound nerve deafness who get little or no benefit from hearing aids. The FDA approved the first commercial Cochlear devices during the mid-1980s.

The FDA said in separate letters to patients and doctors that deaf children who have a Cochlear implant and a positioner get bacterial meningitis more frequently than either children with the implants that don't have the small rubber wedge or those without implants at all. This specific rubber wedge was at first used to help doctors position the implants during surgery. Advanced Bionics Corp. was the only manufacturer to market the implants with positioners.  None of these devices have been implanted in patients since July 2002.

An initial study found that 26 of 4,264 children with the implants developed meningitis during the first two years following surgery and that those with positioners were at greater risk. A recent new study that followed the same children for an additional two years found another six with infections.  All with positioners had developed meningitis. The results appear in the February 2006 issue of the journal Pediatrics. Beyond monitoring cochlear implant patients for signs of meningitis, which include high fever and a stiff neck, the FDA recommends that the children receive proper vaccinations.

Legal Help For Victims Affected By Cochlear Implant

If you or a loved one suffered injuries from a Cochlear implant, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


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Cochlear Implant Made by Advance Bionics Recalled

Nov 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...

Cochlear Implant Lawsuit Not Preempted, Judge Says

Aug 26, 2008 | Parker Waichman LLP
A lawsuit against the makers of a cochlear implant can go forward, a federal judge in Texas has ruled, because a Supreme Court decision  that gave medical device makers protection from product liability lawsuits does not apply to this case.  In her opinion, US District Court Judge Barbara Lynn wrote that  preemption was not warranted in the case because “plaintiffs’ strict liability claims are predicated solely on violations of federal law."In February, the...

Advanced Bionics Faces Fine Over Defective Cochlear Implant Hearing Aids

Mar 31, 2008 | Parker Waichman LLP
Advanced Bionics, LLC, a maker of cochlear implant hearing aids, could face a stiff fine from the Food & Drug Administration  (FDA) for manufacturing violations that may have resulted in dangerously defective hearing aids.  The FDA has alleged that Advanced Bionics failed to follow manufacturing standards and wants to fine the California medical device manufacturer $2.2 million.  Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator in...

Bacterial Meningitis Kills Two Children with Cochlear Implants, Prompting FDA Warning

Oct 11, 2007 | Parker Waichman LLP
Children with Cochlear implants are at a higher risk for developing bacterial meningitis, a potentially deadly infection, and must be fully immunized against the disease.  That warning came from the Food & Drug Administration (FDA) after it learned that two children with Cochlear implants had recently died from bacterial meningitis.A Cochlear implant is an electronic hearing device that works by stimulating nerves inside the inner ear.  It is designed to produce useful hearing...

FDA Issues Updated 'Advice for Patients' Regarding Meningitis Risk Associated with Cochlear Implants

Feb 7, 2006 | Newsinferno News Staff
Cochlear implants are implanted electronic hearing devices that are designed to produce useful hearing sensations people with severe to profound nerve deafness by electrically stimulating nerves inside the inner ear.The devices are designed to help severely to profoundly deaf adults and children who get little or no benefit from hearing aids. Individuals with severe or profound "nerve deafness" may also benefit from cochlear implants.On September 25, 2003 (updating original notice of...

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