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Cochlear Implant

IF YOU OR YOUR LOVED ONE HAS EXPERIENCED A FAILED OR FAILING COCHLEAR IMPLANT, PLEASE READ BELOW. WE MAY BE ABLE TO HELP.
INJURED BY A RECALLED IMPLANT? CALL (901) 527-4673 AND ASK FOR TIM EDWARDS.

IF YOU ARE HAVING PROBLEMS WITH YOUR COCHLEAR IMPLANT, CALL TIM EDWARDS OR ED WALLIS TODAY AT (901) 527-2125.

YOUR RESOURCE ON THE RECALLED ADVANCED BIONICS HIRES90K.

The Recall

In 2004, Advanced Bionics issued a recall for the Clarion CII-x HiResolution 90k (HiRes90k) bionic ear system. Although it is not known why, Advanced Bionics eventually began to ship the HiRes90k again later in 2004 after the United States Food and Drug Administration (FDA) performed an onsite inspection at the Advanced Bionics facility in California. It is believed that before the precise cause of the moisture was known, Advanced Bionics began to ship the cochlear implant again.

Shortly thereafter, in February 2005, the FDA issued a Warning Letter to Advanced Bionics. Prior to the Warning Letter, the FDA issued a FDA Form-483 to Advanced Bionics.

Advanced Bionics issued a second recall on Vendor B HiRes90k implants in March 2006. Note that the second recall was only for HiRes90k implants containing a feedthru component manufactured by Astro Seal, Inc. (which is “vendor B”).  Both recalls were for unimplanted units only. Therefore, if you were implanred before the first recall with a vendor B HiRes90k, or between the first and second recall with a vendor B HiRes90k, the recall would not affect you. The decision was made to leave the implant inside of you until the unit/device failed.

It is believed more than 30% of HiRes90k vendor B units have or will fail.

In 2007, the FDA filed a civil complaint against Advanced Bionics seeking $2.2 Million dollars in fines against Advanced Bionics and co-CEO/President Jeffrey Greiner. The HiRes90k cochlear implant 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.” Click here for copies of the Complaint or Amended Complaint.

The Settlement

Advanced Bionics has settled the Complaint with the FDA, agreeing to pay $1.1 Million Dollars in fines for alleged wrongdoing. The company’s CEO has also agreed to pay a $75,000.00 fine. Advanced Bionics denies wrongdoing. A copy of the Settlement Agreement is HERE.

Your rights

You have the right to seek damages from Advanced Bionics for pain and suffering, medical expenses, travel expenses, time off of work, educational delays, emotional distress and more. Even if you have accepted funds from Advanced Bionics, you may still be entitled to relief. Contact us.

Pursuant to state law, you must pursue your rights within a time period known as the statute of limitations. Therefore, you should not delay and should contact an attorney as soon as possible if you believe you have sustained physical or emotional injuries as a result of the recalled HiRes90k.

Why file a lawsuit?

It can be argued that Advanced Bionic’s failure to follow FDA regulations and guidelines shows a disregard for the safety of patients. Causes of action may exist for design defects, breach of warranty, consumer protection, negligence, intentional wrongful and more. You should contact us today for a free consultation on your case. Call Tim Edwards or Ed Wallis today at (901) 527-2125. After hours and on weekends, call (901) 275-0600.

Symptoms

Possible symptoms of injuries include:

  • Discomfort
  • Ear pain
  • Loss of sound
  • Cracking, hissing and popping noises
  • Huming
  • Sudden loud noises

If you believe you have sustained any injuries, please seek medical help IMMEDIATELY. If your child is not showing proper development advances, and you suspect his or her cochlear implant is malfunctioning, please seek medical help IMMEDIATELY.

The Authors’ Connection

Tim Edwards, an author of this blog, has a personal connection to cochlear implants and this specific allegation of wrongdoing by Advanced Bionics. Tim’s grandson was born completely deaf, and at twelve months of age, he was implanted with an Advanced Bionics HiRes90k cochlear implant. While Tim’s grandson today has experienced no symptoms of a failing device, he is a part of the recalled group, and must live day by day never knowing when his implant might fail.

Tim has a strong, personal connection to these cases, and is passionate about seeing that justice prevails for his clients.

More Information and Resources

In order to help you understand the recall, the allegations against Advanced Bionics, and the current status of the dispute over the HiRes90k bionic ear system, the following links may be of assistance. We plan to continue adding more content, so please continue to check back or send us an E-MAIL if you have questions or information to contribute.

Experience

Tim Edwards and Ed Wallis are repsenting children and adults internationally who have received a HiRes90k or CII cochlear implant device that failed prematurely. If you would like to discuss the specific facts of your case with Mr. Edwards or Mr. Wallis, please call (901) 527-2125 / (901) 275-0600 (after hours), or SEND US AN EMAIL.

General Information

Press Releases and Documents

FDA Lawsuit Documents

Other Links

The Authors and The Process of Filing Suit

If you have questions on us generally, please see:

Contact Us Today.

Attorneys Tim Edwards and Ed Wallis are currently representing injured persons who received the HiRes90k cochlear implant and stand ready to discuss your case with you. If you were a recipient of an Advanced Bionics HiRes90k Cochlear Implant or an earlier Clarion II / CII implant, and the device has failed or you suspect failure, please contact us:

Tim Edwards
Ed Wallis
Glassman Edwards Wade & Wyatt
26 N. 2nd Street
Memphis, TN 38103
(901) 527-2125
(901) 275-0600 (after hours / weekends)
ewallis@gewwlaw.com

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