Table of Contents
- 1 Cochlear Implant
- 2 Cochlear Implant Surgery Side Effects
- 3 Complications in cochlear implants
- 4 Cochlear Implant Failure Story
- 5 Settlements for Advanced Bionics
- 6 Advanced Bionics Cochlear Implant Lawsuit
- 7 Advanced Bionics Cochlear Implant Lawsuit Recall 2020
- 8 Advanced Bionics Cochlear Implant Lawsuit Recall 2021
- 9 Eligibility for the Advanced Bionics Lawsuit
Do you realize how amazing it is to see a child listen and respond to what their parents are saying? Unfortunately, some kids are born with disabilities. One such common disability among children is loss of hearing. This disability makes it difficult for children to interact with others and survive. Due to this circumstance, their parents’ happiness will also be ruined.
As a solution, a surgery called cochlear implants helps children experience the joy of hearing and connecting with their loved ones.
However, due to various factors, Cochlear implants can fail due to technical malfunctions or the body’s response to the implant.
There have also been cochlear implant lawsuits filed against the existing brands. In this blog, we shed light on the complexities from top to bottom surrounding this life-changing technology. Let’s discuss them one by one.
A cochlear implant or bionic ear is a surgically implanted electronic device that helps with hearing loss or deafness by bypassing damaged parts of the inner ear called the cochlea and directly stimulating the auditory nerve, which allows one to perceive sound and speech.
Cochlear implants are manufactured by
- Cochlear Corporation
- Advanced Bionics Corporation
- Med-El Corporation
In the United States, more than 41,000 adults and 29,400 children had cochlear implants, which helped restore enough hearing to allow for unaided speech understanding.
Cochlear implants can be implanted in infants from 10 to 12 months old. Evaluations for a child to get a cochlear implant at this age should begin around 3 to 4 months. A congenitally deaf child needs cochlear implant surgery before the age of three or earlier.
Cochlear implants latest technology is created with the newest sound processor called CochlearTM Nucleus 8, commonly known as the N8 or CP 1110, and it is manufactured by Cochlear Ltd., the market leader for cochlear implants globally.
However, children have the best opportunity to learn to use sound while developing language abilities because of this early implantation.
Despite the fact that these devices can be very helpful for users, design flaws have led to a number of Cochlear ear implant recalls. Many users have reported side effects like loud noises, pain, mental shock, and other issues after the surgery. Now let’s briefly see the side effects that have been caused by Cochlear implants.
Cochlear Implant Surgery Side Effects
Although cochlear implants are renowned for their effectiveness in helping the disabled, there have been reports of certain potential negative effects following the procedure.
Here are some reasons for the common side effects associated with cochlear implants:
Tinnitus can occur as a result of electrical stimulation from the implant. The brain may interpret this stimulation as sound, leading to the perception of ringing or buzzing.
Dizziness or vertigo
These sensations can result from the surgical procedure itself as well as the introduction of electrical signals to the auditory system, which may initially cause a sense of imbalance.
Infections can happen due to the surgical implantation process, as with any surgical procedure. Strict sterile techniques are used to minimize this risk.
Facial nerve weakness
During the implantation surgery, proximity to the facial nerve can occasionally lead to temporary weakness or irritation, though this is rare.
Change in taste
Altered taste sensations can occur if the implant’s electrodes stimulate nearby taste nerves during surgery.
Device malfunctions can arise from various factors, including manufacturing issues or electrode migration over time. These issues may require device adjustment or replacement.
According to the survey, more people experience tinnitus as a side effect than other adverse effects.
Complications in cochlear implants
Cochlear implantation has evolved into a common surgical treatment. As a result of the rise of cochlear implant candidates in recent years, the potential drawbacks of cochlear implant surgery have also increased.
The numerous types of minor and significant problems are illustrated in this article.
The following are the main traits of the significant complications:
Facial nerve stimulation
Patients with abnormal ears experience facial nerve stimulation, or even those without any known pathology, frequently
Reprogramming specific electrodes will lessen the condition, but a significant decline in speech recognition is unavoidable.
It has been observed that when a straight electrode was implanted, replacing it with a modiolar hugging electrode lessened this symptom; however, it cannot be used in all circumstances, hence there is currently no effective cure.
Poor auditory nerve response
Poor auditory nerve response can happen in some congenitally deaf children or people who have ossified cochlea and are post-lingually deaf.
Patients may only be aware of background noise or stop using their cochlear implants. Another option for treatment could be reimplantation on the other side or an auditory brainstem implant.
Electrode extrusion or migration of the electrode
After surgery, electrode extrusion or migration of the electrode array may take place.
This problem can have a variety of causes, although it should be less common because of the split bridge approach, tight packing around the cochleostomy window, or canal wall rebuilding.
Only a small percentage of cochlear implantation instances result in infections, but there is a chance that these infections could progress to meningitis and cause mortality.
Although the majority of infections resolve in response to medical care, revision surgery is required when the skin deteriorates. Therefore, it is crucial to be aware of the early stages of infection.
Surgeons must learn from prior errors and undergo implantation training in order to reduce the rate of significant complications. Because certain issues are brought on by defective devices, producers must enhance the integrity and design of their products to achieve successful results.
Cochlear Implant Failure Story
Advanced Bionics is ranked as the second-largest producer of cochlear implants. However, they had an issue with the HiRes 90K implant, a model of their product, and it was discovered that these devices were a failed model with flaws in excessive moisture. However, advanced bionics continued to sell these products.
A cochlear implant is placed on a 3-year-old, Grace Bagadiong, but as a result, she suffered a lot from the decision of advanced bionics to keep selling the implants.
Grace had previously experienced an unknown ailment that caused her left side to be non-functional, but at age 3, the child has become entirely deaf.
However, medical professionals advised her parents that cochlear implant surgery might restore their daughter’s hearing. The child’s parents gave their consent for the procedure, and the cochlear implant was placed in her.
In 2005, Grace was implanted with the HiRes 90K. Three months after Grace’s operation, her parents got a letter informing them that the device inside Grace’s skull was being recalled due to multiple failures.
The history of cases filed against advanced bionics before Grace’s implant is given below.
- An Advanced Bionics engineer issued a warning in January 2003 that a crucial implant component would be susceptible to a leak.
- An Advanced Bionics official acknowledged in March 2004 that the business has not carried out a crucial test that simulates the human body.
- An FDA investigation in August 2004 uncovered 237 explanted devices with excessive moisture levels.
- Advanced Bionics HiRes 90k were recalled in September 2004 because of “unexplained moisture” that may have contributed to certain implant failures.
- The Advanced Bionics HiRes 90k was brought back to the market in November 2004.
- The FDA issued a warning notice to Advanced Bionics in February 2005.
- Summer 2005: Advanced Bionics is still receiving complaints of implants that have failed owing to too much moisture.
The president of Advanced Bionics’ business declared in February 2005 that “product failures continue to occur at an alarming rate.
Settlements for Advanced Bionics
In 2008, Advanced Bionics agreed to a $1.1 million settlement for a cochlear implant lawsuit with the FDA while denying the defective cases. A Kentucky jury found Advanced Bionics responsible for Breanna’s case. Her implant failed in December 2009 due to a feedthru leak, which enabled moisture to enter the device and resulted in an intense shock. Breanna writhed on the ground. This case fined the company more than $7 million. Then, Breanna’s case, Grace’s case, and a few others were resolved.
Advanced Bionics Cochlear Implant Lawsuit
Many firms perform cochlear implant surgery, but the issues and data show that this procedure has certain risks for the patient when defective products are used.
Many people have filed cochlear implant lawsuits against the firms that performed cochlear implants.
A cochlear implant lawsuit is filed on behalf of the U.S. government against Advanced Bionics, a manufacturer of cochlear implants. The information was passed on by a whistleblower, who alleged the company misled Medicare, Medicaid, and other government health programs.
It also insists that some cochlear implant processors contain radio-frequency emissions. Importantly, Advanced Bionics represented to the FDA that its cochlear implants met an internationally recognized emissions standard when they didn’t and then sought reimbursement from the government for these devices.
The Department of Justice (DOJ) announced in December 2022 that it had settled the matter with Advanced Bionics for more than $12 million.
According to reports, the business has also been the target of personal injury claims relating to its recalled HiRes 90K cochlear implant, which is said to have given some users “painful shocks to the head.” In one instance, a Kentucky jury reportedly awarded a girl aged 8 who allegedly suffered “severe electric shocks” in her head as a result of the gadget more than $7 million. Now, if you are wondering, is this a class action lawsuit?
The answer is no because attorneys handling the lawsuit believe patients using Advanced Bionics cochlear implants have suffered injuries serious enough to warrant individual cases. Usually, class action lawsuits are filed for less severe harm.
Advanced Bionics Cochlear Implant Lawsuit Recall 2020
Due to an increase in reports of hearing loss and revision procedures, Advanced Bionics declared in early 2020 that it would be starting a field corrective action for its HiRes Ultra and Ultra 3D cochlear implants.
The business specifically mentioned that some patients had encountered performance concerns as a result of body fluid getting within the electrode, which could impair the device’s operation.
The HiRes Ultra and Ultra 3D were recalled by Advanced Bionics as part of the recall, and the company cautioned users who were having issues with the devices that they could need revision surgery to remove the old implant and replace it with a newer model.
The manufacturer had claimed at the time that less than 0.5% of recipients needed the implant removed, but research by famous Swiss otolaryngologist Thomas Lenarz revealed a startling failure rate for the gadgets.
More than 50% of the 349 patients who received the HiRes Ultra and Ultra 3D cochlear implants at his German facility encountered the issues detailed in Advanced Bionics’ recall. The study discovered that the median interval between device implantation and the emergence of probable failure-related performance concerns was less than three years, and about 35% of these individuals had already had their devices removed.
Advanced Bionics Cochlear Implant Lawsuit Recall 2021
According to the report in the cochlear implant lawsuit from Neue Zurcher Zeitung (New Journal of Zurich), the Swiss newspaper of record, fifty percent of defective cochlear implants are manufactured by Advanced Bionics. Less than one percent failure rate is predicted for cochlear implants.
Advanced Bionics defective implant allows moisture to enter the product and short-circuit the electronics, which require removal and replacement. Children were seriously put at risk due to Advanced Bionics’ delayed disclosure.
Eligibility for the Advanced Bionics Lawsuit
Any person or a child who suffered due to defective can file a cochlear implants lawsuit. If you or any of your family members have suffered any personal injuries, you can file a product liability lawsuit. It is important to find a cochlear implant lawsuit attorney and have a case evaluation. It is necessary to keep your medical records safer. It can increase your attorney’s chance of winning your case. Companies like LezDo TechMed assist with the lawsuit by reviewing the medical records of the plaintiff and building strong cases.
Visit our Instagram account for additional insights:
View this post on Instagram