On November 6, 2021, the Swiss newspaper of record, Neue Zurcher Zeitun, reported that clinics in Germany and Switzerland found defects in 50% of cochlear implants manufactured by Advanced Bionics. The expected failure rate should be less than one percent.
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What are Cochlear Implants?
The FDA first approved cochlear implants in the mid-1980’s to treat hearing loss in adults; however, since 2000, cochlear implants have been FDA-approved for use in eligible children beginning at 12 months of age.
Illustration of cochlear implant.
Cochlear implants are used to improve understanding of speech and spoken language, whereas, hearing aids make sound louder but do not improve speech understanding. A cochlear implant delivers sound directly to the auditory nerves in the cochlea, or the inner ear, allowing sound to reach the brain. It works by electronically stimulating nerves inside the inner ear responsible for hearing.
This complex electronic device consists of 1) an external microphone and speech processor, and 2) an implanted receiver and electrode array system. The receiver/stimulator is what transmits electrical impulses by electrodes directly into the auditory nerve.
What is the Defect?
The defect in the Advanced Bionics implant allows moisture to enter and short-circuit the electronics. Surgery is necessary to remove and replace the defective cochlear implant. In addition, patients will undergo months of readapting to the new device.
The risks of a reimplantation surgery are significant. There is a risk of damaging the auditory nerve. After surgery, readapting to the device is often a long process that takes months – time that is critical for young children and often during optimal early years of language development.
A product liability claim may be pursued with a defective product. This is when a product has malfunctioned, did not work the way it was supposed to, or was too dangerous to operate resulting in injuries. An entity, such as a manufacturer, distributor or seller of the product may be held accountable for a product that results in injury or even death.
- A product can be considered defective when it fails to conform to the manner it was intended. With cochlear implants, the FDA has asserted that Advanced Bionics failed to adhere to certain manufacturing standards.
- In addition, the device was to improve hearing loss. Excessive moisture caused the device to malfunction leading to permanent hearing loss or making current hearing worse.
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Advanced Bionics Cochlear Implants
Advanced Bionics, located in Valencia, California, is a subsidiary of the Swiss hearing aid manufacturer, Sonova, and is a leading manufacturer of cochlear implants. Approximately 19,000 HiRes Ultra and HiRes Ultra 3D implants manufactured by the company are in use, of these 6,000 are used by children.
- The HiRes 90K devices were found to have excessive moisture inside, resulting in frequent failure and sometimes a strong shock to the person. Problems were first reported internally in 2003 yet the company did not recall the devices implanted until 2006. Defective cochlear implants shocked kids – even though company had been warned
- In 2007, the company had an identical defect in previous models of the devices. The FDA’s Center for Devices and Radiological Health sued the company for not obtaining pre-market approval for a HiRes component (feedthrough assembly component) that caused an excessive moisture problem that patients were not aware of. This exposed patients to the risk of device failure, risks of surgical intervention and potential permanent loss of hearing. While Advanced Bionics recalled the cochlear implants, the defective product was sold and implanted after the recall.
- In 2013, a jury awarded $7.25 million to a child who suffered electric shocks caused by a defective Advanced Bionics implant. She was shocked two more times before the device was removed and replaced. The jury awarded punitive damages because it found that Advanced Bionics had delayed recalling the product so they could sell more devices.
- Defects in the Ultra HiRes and Ultra HiRes 3D were first reported to Advanced Bionics in the summer of 2019 yet the company still continued to sell defective cochlear implants.
- February 17, 2020, Advanced Bionics initiated a recall of its implants. The company reported “fluid ingress at the electrode.” The company notified recipients of “prolonged hearing degradation due to physiological fluid entering into the electrode (not the hermetic seal of the device body) and causing interruption of stimulation that can negatively affect device performance.”
Advanced Bionics filed a PMA with the FDA on October 1, 2019. It was approved on December 23, 2019. This means that replacements for the HiRes implants were commercially available in 2019.
Cochlear implants have been recalled by the FDA multiple times and the companies that make them, such as Advanced Bionics, are not always upfront with patients.
Complications of Defective Cochlear Implants
- Loud noises inside the inner ear
- Device failure, intermittent functioning
- Cracking or popping noises
- Pain throughout your face or subtle shocks to your face
- Violent outbursts in children
- Reduced hearing in patients
Cochlear implant example.
Side effects and complications from removing and reimplantation surgeries:
- Total hearing loss
- Bacterial meningitis (swelling of brain and spine)
- Tissue death
- Facial nerve damage
- Cerebrospinal fluid leakage
- Perilymph fluid leak
- Skin wound infection
- Blood or fluid collection at surgical site
- Dizziness or vertigo
- Tinnitus (ringing in the ears)
- Sensory trouble (i.e., taste is affected)
- Numbness around ear
- Inflammation and implant rejection
FREE CASE EVALUATION FROM DEDICATED, EXPERIENCED ATTORNEYS
Cochlear implant lawsuits have been filed which accuse Advanced Bionics of designing a defective product and failing to warn about its risks.
It can be devastating when the medical devices you rely on fail. The Nash & Franciskato Law Firm has a proven track record against medical device manufacturers.
What we offer goes beyond experience. Our legal team is dedicated to you and helping you put your life back together, giving you:
- Over 80 years of combined experience
- Trusted legal advisor committed to your needs
- Free, no-obligation review of your case
- Super Lawyers for over 10 years
- The AV Preeminence Rating for Ethical Standards & Legal Ability
- Compassionate advocacy for you and your family
Consult an attorney who knows defective medical products.
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If you or a loved one has suffered from a defective cochlear implant, contact the law offices of Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is today. We will review your case in a free and confidential consultation, with no risk or obligation to take legal action.
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