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.