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Cochlear ear implants, manufactured by Advanced Bionics, can be very effective, even miraculous, in helping deaf and hard-of-hearing individuals gain the ability to perceive and experience sound. Unfortunately, at the same time, cochlear ear implants have a history of serious problems and defects.

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.
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  • 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.

How cochlear implants work

Unlike hearing aids that amplify sound for the ear, a cochlear implant is surgically implanted. It is designed to stimulate the auditory nerve, bypassing the damaged portions of the ear.

Hearing through a cochlear implant takes time to adapt, learn or relearn. 6000 of the 19,000 HiRes Advanced Bionics cochlear implants are used by children. They are exposed to the implant early in order to be able to perceive sounds during the optimal age in which to develop speech and language skills. 

Studies have shown that when children receive a cochlear implant followed by intensive therapy before they are 18 months old, they are better able to hear, comprehend sound and music, and speak than those who receive implants when they are older.

Removal and replacement of ear implants can be risky and harmful

Surgery is necessary for everyone with a defective Advanced Bionics cochlear implant, followed by months of readapting to the new device. The risks of a reimplantation surgery are significant. In removing and replacing damaged electrodes, there is a risk of damaging the auditory nerve. 

This set back can be devastating to the development of young children, who have to experience the risks of replacement surgery and begin adapting to it again.

Advanced Bionics filed a PMA (Premarket Approval) with the FDA on October 1, 2019, and it was approved on December 23, 2019. This filing was done with full knowledge of the defective implants discovered in the summer of 2019. As soon as Advanced Bionics knew of this, they should have issued an immediate warning, especially for children, whose language development can be irreparably delayed or who can be harmed by replacement surgery.

How we can help

While cochlear implants can radically change the lives of people experiencing hearing loss, individuals should have expert and aggressive legal counsel in their corner if something goes wrong. And for those who have experienced trauma, setbacks or other physical or emotional distress because of defective cochlear ear implants, we will advocate for you to ensure you receive the damages you are entitled to.

If you or a loved one is suffering from complications following a cochlear implant procedure, contact us today to learn how we can help.

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