Defective Ear Implants

FDA Recalls and Warnings About Cochlear Ear Implants

Cochlear implants have been recalled by the FDA multiple times because of defects. In subsequent investigations, it came out or has been suspected that Advanced Bionics has not always been forthcoming with their consumers. This has been devastating for families and individuals who trusted in the proper function and efficacy of ear implants and experienced further loss of hearing or other damage. The following are only a few of the incidents that have occurred:

• 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.
• 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 2020, 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.
• 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 device.
• 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.