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In late 2010, a cochlear implant manufacturer initiated a recall of one of its devices, the HiRes90k, because of potential injury to the recipients of the device. A cochlear implant is an electronic device that allows sounds to be heard by those with severe hearing loss and the completely deaf. Also referred to as a bionic ear, cochlear implants differ from hearing aids in that they stimulate the auditory nerve rather than simply amplifying sound.
Advanced Bionics (AB) is a subsidiary of Boston Scientific Corporation. It has a long history of defective Cochlear implant recalls involving the HiRes90k, as well as problems with the U.S. Food and Drug Administration (FDA), which regulates the devices.
In 2004, AB issued a cochlear implant recall due to residual moisture in the circuitry. In 2005 the FDA issued a warning letter to alleging a significant manufacturing deficiency. In 2006, the company issued a second worldwide cochlear implant recall.
In 2007, the FDA and AB settled a civil complaint for $1.1 million in fines. The FDA stated that the HiRes90k could "pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss."
The HiRes 90k system is now once again the subject of a cochlear implant recall. Advanced Bionics also announced that it is retrieving all unimplanted devices in distribution. While the exact nature of the current defect has yet to be determined, it has caused serious injuries in some of the recipients of the device. The injuries that have been experienced include severe pain, overly loud sounds, and/or shocking sensations.
If you have been injured by this cochlear implant procedure, or have received a device subject to a cochlear implant recall, you should contact an experienced cochlear implant attorney. Your attorney may be able to help you receive compensation. A cochlear implant lawyer will be able to advise you whether you should file an individual lawsuit, or join a possible class action lawsuit if one exists.
To find out your rights to compensation, contact our cochlear implant attorneys today. Send us an email and someone from our firm will be in touch with you shortly.
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