Did you or someone you know receive a cochlear implant from Advanced Bionics? If so, you should take note that the Food and Drug Administration (FDA) announced in March 2008 that it was “seeking a $2.2 million penalty against a California hearing device manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.”

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. The cochlear implant is often referred to as a bionic ear. 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 which also allows an individual to adjust the sound for quality and amplification.

Model HiRes90k (also referred to at the CII-x) was alleged by the FDA to “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.” Overall, the FDA sought damages against both Advanced Bionics and the company’s CEO for violating numerous federal laws including reporting to the FDA. We would invite you to contact us for more information.

Memphis, Tennessee attorneys Tim Edwards and Ed Wallis have reviewed numerous cases in around the globe concerning defective cochlear implants and are available to discuss your specific case, questions or concerns. If you were a recipient of an Advanced Bionics HiRes90k Cochlear Implant (or a CII in limited circumstances), and have experienced physical or emotional injuries due to a malfunctioning implant, please send an e-mail immediately and we will respond to you.

Also, feel free to visit our Cochlear Implant Page for more information. Please also fill out this form: