Cochlear Implants

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Cochlear Implants & FDA Warnings

What is a cochlear implant? Sometimes called a bionic ear, it is an implantable electronic device for deaf or nearly deaf people. Using microphones, processors, and transmitters it can mimic natural hearing through electronic signals and the auditory nerve.

FDA Guidelines & Criteria for Cochlear Implants

Cochlear implants are designed to help profoundly deaf adults and children, especially those who get little or no benefit from hearing aids. Approximately 23,000 adults and 16,000 children already have cochlear implants. In general, cochlear implants are typically provided to children between 2 and 6 years old. However, the U.S. Food and Drug Administration (FDA) has approved one type of cochlear implant for use in children who are 1 year old.

FDA Approval of Cochlear Implants

While the research into cochlear implant technology began decades earlier, the FDA approved the first commercial devices in the mid-1980's. Since that time there have been consistent and significant advances in the devices.

FDA and HiRes 90K Cochlear Implant Device Recall

In late 2010 Advanced Bionics, a leading maker of implants, initiated cochlear implant recall of its HiRes 90K device citing an unspecified defect that poses a serious risk to its users. This is just the latest in a string of problems for the implant maker and the device.

In 2004, Advanced Bionics issued a cochlear implant recall for its Clarion and HiRes 90k systems due to residual moisture in the circuitry. In 2005, Advanced Bionics received an FDA Warning Letter alleging a significant manufacturing deficiency. In 2006, the company issued a second worldwide cochlear implant recall of the HiRes90k.

In 2007, the FDA filed a civil complaint against Advanced Bionics seeking $2.2 Million dollars in fines against Advanced Bionics, which the company settled for 1.1 million. The FDA warning stated that the HiRes90k could "pose a public health risk … and the potential for additional hearing loss."

The causes of the problems behind this latest cochlear implant recall have yet to be determined, but the injuries they've caused are serious. Recipients have experienced problems including electric shocks, severe pain, and overly loud sounds.

Contact a Cochlear Implant Attorney

Have you or a loved one suffered from cochlear implant injuries ?If so, consult with a cochlear implant attorney who can help you seek compensation for the damages you suffered.

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