In August, Advanced Bionics announced that 16% of implants worldwide are defective. The numbers found by the renowned Hannover Hearing Center are even higher - of the 349 patients studied 50% were determined to be defective. These findings are alarming when compared to the expected failure rate for cochlear implants which is less than one percent.
Here is what you need to know about the cochlear implant defects:
How does a cochlear implant work?
A cochlear implant is a permanent alternative to hearing aids. The device is an intricate electronic device that provides a sense of sound to a profoundly deaf or severely hard-of-hearing person. The receiver/stimulator transmits electrical impulses that bypasses the damaged portions of the ear and stimulates the auditory nerve.
Cochlear implants are designed to last a lifetime. Because of this, implantation is taxing. The surgery involves drilling through the mastoid area of the temporal skull to connect the device to the auditory nerve. The procedure is not only costly but is followed by months of adapting to the device.
Why are Advanced Bionic cochlear implants defective?
According to investigations by NZZ am Sonntags, the first problems with the implants reported to Advanced Bionics after discovery back in summer of mid-2019 by the world-renowned German Hearing Center at the Hanover Medical School.
The defect allows moisture to enter and short-circuit the electronics, which require removal and replacement. An internationally recognized specialist stated “body fluid penetrates at the point where the implant should transmit signals to the auditory nerve. That leads to short circuits that damage the device.”
Which Advanced Bionic cochlear implants are faulty?
The initial versions of Advanced Bionics HiRes Ultra and Ultra 3D cochlear implant devices have shown a decrease in performance.
Timeline of events:
- In 2007, the FDA’s Center for Devices and Radiological Health sued and was awarded $1 million from Advanced Bionics because they did not get FDA-required premarketing approval for a new development in their device. Their new device assembly caused an excess of moisture that contributed to permanent hearing loss.
- Advanced Bionics was also the defendant in a 2013 Kentucky case that found that an 11-year-old girl suffered electric shocks and convulsions from a defective cochlear implant. Advanced Bionics was ordered to pay her family $7.25 million. The jury awarded punitive damages against Advanced Bionics because it had delayed recalling the product to continue sales. That means that the company acted willfully, intentionally, or recklessly, in conscious disregard of the safety of its customers.
- Defects in the Ultra HiRes and Ultra HiRes 3D were first reported in the summer of 2019 to Advanced Bionics by the German Hearing Center at the Hanover Medical School. The German Hearing Center is the world-renowned provider of cochlear implants. Internationally recognized specialist, Dr. Thomas Lenarz, Director of the Clinic for Ear, Nose, and Throat for the German Hearing Center, reported to a Swiss journalist that "body fluid penetrates at the point where the implant should transmit signals to the auditory nerve. That leads to short circuits that damage the device."
- From the information gathered thus far, researchers believe that Advanced Bionics continued to sell defective implants after receiving warnings in 2019 from German surgeons.
- In a statement released on March 10 2020, following reports of performance issues, Advanced Bionics issued a voluntary field corrective action for initial versions of HiRes Ultra and Ultra 30 cochlear implant devices. The failure rate at the time was very low, which is why Sonova did not react immediately.
- Only 6 months later in February, Advanced Bionics announced a recall of the HiRes Ultra and Ultra 3D cochlear implant devices after receiving reports of hearing performance degradation caused by the device. In the cases where the device was removed, fluid had affected the implant.
- Most recently, on November 6, 2021, the Swiss newspaper Neue Zurcher Zeitung (New Journal of Zurich) reported that clinics in Germany and Switzerland found defects in a shocking 50 percent of cochlear implants manufactured by Advanced Bionics. The expected failure rate for cochlear implants should be less than one percent.
- However, investigation indicates that Advanced Bionics continued to sell older defective implants after receiving the warning in summer, 2019, from German surgeons. They received this information from reputable German surgeons well before the issued their February 2020 recall of the devices.
What are the implications of a defective cochlear implant?
Not only do those with a defective implant face the daunting future of undergoing a corrective surgery, but there are significant risks associated with the surgery and will endure a long road to recovery. Hearing through a cochlear implant takes time to adapt, learn, or relearn.
For young children, there is no time to spare. Every minute is crucial for a child to acquire language for it is a tragedy to undergo replacement surgery and begin adapting to it again. Approximately 19,000 cochlear implants manufactured are in use, 6,000 of which are children.
Why pursue a product liability claim for a defective cochlear implant?
According to Neue Zurcher Zeitung, investigation indicated that Advanced Bionics continued to sell older defective implants after receiving a warning in the summer of 2019 from German surgeons well before issuing a warning and the February 2020 recall of the device. Advanced Bionics failed to protect their unsuspecting consumers. The global corporation must be held accountable for their negligence that put the lives of hundreds in danger.
How can Meyers & Flowers Trial Attorneys help?
If your doctor is asking to replace your Advanced Bionics cochlear implant, make sure to ask the medical team for the explanted device to be preserved and given back. All recipients of Advanced Bionics cochlear implants losing frequencies should be evaluated by their audiologists. If the device is failing to meet specifications, contact the experience product liability trial attorneys at Meyers & Flowers to explore your legal options. There is no charge for a consultation, and you will pay nothing unless we win.