Cochlear Implant
In 2004, Advanced Bionics issued a recall for all unimplanted Clarion and HiRes90k bionic ear system cochlear implants. The company stopped shipping all cochlear implants for several weeks, and in November 2004, began to ship the devices again. If you were implanted after September 2004, it is possible you were never told about the September 2004 recall.
In February 2005, Advanced Bionics management stated that device failures were continuing at an alarming rate. The same month, the FDA issued a Warning Letter to the company. You can obtain a copy of the Warning Letter by CLICKING HERE.
In March 2006, the company issued a second worldwide recall of the HiRes90k cochlear implant device, but this recall included only unimplanted devices that contained a feedthrough component manufactured by AstroSeal, Inc. AstroSeal has been referred to frequently as “vendor B.” Advanced Bionics no longer uses vendor B feedthroughs in its cochlear implant devices.
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 then 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 FDA Amended Complaint.
Advanced Bionics settled the Complaint with the FDA, agreeing to pay $1.1 Million Dollars in fines for alleged wrongdoing. The company’s CEO also agreed to pay a $75,000.00 fine. Advanced Bionics denied wrongdoing. A copy of the Settlement Agreement is HERE. Advanced Bionics also gave two WEBINARS to patients after the settlement became public knowledge.
What Your Rights Are
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. You should contact us to explore this situation.
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 Clarion or 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. For more information on how we can help, contact us now.
Symptoms
Please note that the first step if you believe you have suffered a cochlear implant failure is to immediately call your audiologist and/or surgeon. While the possible symptoms of device failure include the following, there are many other symptoms that could be applicable to your situation:
- Discomfort
- Ear pain
- Loss of sound
- Cracking, hissing and popping noises
- 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.
Our Co-Counsel’s Connection
Tim Edwards, lead counsel of our team of cochlear implant lawyers, 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 received a recall letter in September 2004 and lived for years in fear that his grandson’s device would fail.
Tim has a strong, personal connection to these cases, and is passionate about seeing that justice prevails for his clients. He is currently serving as a Board of Director to the Memphis Oral School for the Deaf in Memphis, Tennessee, and his grandson attends an oral school in Texas.
Press Releases and Documents
FDA Seeks Civil Penalties from Calif. Device Maker (Mar. 28, 2008)
Civil Penalties Sought Against Maker of Hearing Aid (April 4, 2008)
FDA Warning Letter (Feb. 1, 2005)
Advanced Bionics Second Recall Letter
Pleadings Filed in Actual Cases By Our Legal Team
Complaint on behalf of an injured adult from Iowa
Complaint on behalf of an injured adult from Kentucky
Amended Complaint on behalf of an injured child from Tennessee
Motion to Request Court Require Advanced Bionics to Assert Fault Against AstroSeal
Motion to Compel Production of Critical Self-Evaluation Privilege Documents
Motion to Compel Production of President of Auditory Division Files
FDA Lawsuit Documents
Amended Complaint Against Advanced Bionics
Settlement Agreement with FDA/Advanced Bionics
Other Links
Journal of Deaf Studies & Deaf Education
Our Team of Attorneys is here to help.
Our co-counsel Attorneys Tim Edwards and Ed Wallis are currently representing injured persons who received the HiRes90k cochlear implant and stand ready to discuss your potential cochlear implant lawsuit. 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:
CALL US TODAY AT 888-655-2923 OR FILL OUT THE FORM ON THE LEFT TO BE CONTACTED AND HAVE YOUR QUESTIONS ANSWERED AT NO CHARGE. DON’T DELAY. ACT TODAY.