Cochlear Implant Lawsuit
Are you or your child victims of medical malpractice where the doctor's negligence led to a cochlear implant mistake? Did the FDA (Food and Drug Administration) recall your Advanced Bionics cochlear implant due to malfunction?
The personal injury attorneys at Rosenfeld Injury Lawyers, LLC can serve as legal advocates for families filing defective cochlear implant claims involving defective cochlear implants.
We can ensure you receive financial compensation for medical bills and other expenses you deserve and possible jury-awarded punitive damages.
Call our defective medical device lawyers at (888) 424-5757 (toll-free phone call) or use the contact form today to schedule a free consultation.
Our law firm treats all information you disclose with our law office as a confidential part of the attorney-client relationship to ensure your privacy.
Parents with children with partial or total deafness feel immense sorrow and distress because they know their child is profoundly deaf.
The parents want to help their children by offering life-changing opportunities, such as the Advanced Bionics cochlear implants.
Since 1972, many individuals with hearing impairments have undergone a cochlear device procedure. Data from the National Institute on Deafness and Other Communication Disorders (NIDCD) revealed tens of thousands of adults and children chose to undergo cochlear implant surgery. Many of these patients were born deaf.
Unfortunately, like all surgeries, cochlear implants are not without risks. For decades, patients with cochlear implants have faced an extensive history of severe complications. The manufacturer has faced implant recalls and cochlear implant claims when the medical device implants malfunctioned.
Advanced Bionics Cochlear Implants
Medical device manufacturers design cochlear implants for adults and children suffering severe hearing loss where traditional hearing devices are ineffective. Unlike hearing aids in each ear, a cochlear implant delivers sound directly to the patient's auditory nerves in the inner ear (cochlea).
Bypassing the ears and sending sound from the cochlea directly to the brain through a small complex electronic device ensures that the previously deaf person has complete or near-complete hearing. Early intervention is crucial to the patient's ability to hear in the future.
Over time, the opportunity for hearing improvement decreases significantly as the individual's hearing loss worsens. Children tend to have substantially more benefits sooner for improved hearing after undergoing surgery, followed by rehabilitation and training to achieve optimal hearing.
Preparing for Advanced Bionics Cochlear Implant Surgery
A cochlear hearing device does not restore the patient's hearing to normal. In addition, in some cases, the surgery does nothing to help the individual's hearing.
While recommending a cochlear medical hearing device, the doctor will likely discuss specific facts about what the procedure entails and what to expect in the days, weeks, and months following the surgery. The particular facts include:
- The therapy will teach the individual how to interpret electrical signals to understand aural and hearing sounds
- Rehabilitation will teach listening skills for better communication
- The device requires recharging or new batteries each day
- The external part of the implant must be removed when swimming, or bathing
Surgeons must perform a particular surgery for patients undergoing an MRI, playing sports or involvement as an accident could damage the implant.
Sometimes, the patient loses their natural hearing in the implanted ear. When this occurs, the individual should use a hearing aid to ensure their natural hearing ability remains.
Cochlear Implants: Risks and Complications
While surgically implanted devices have proved to be beneficial for tens of thousands of patients, others have experienced significant harm, unnecessary potential risks, and life-threatening complications that include:
- Balance issues
- Bacterial meningitis
- Changes in taste
- Device malfunction
- Dry mouth
- Facial nerve injury
- Facial paralysis
- Fluid leakage around the inner ear or brain
- General anesthesia risks
- Inability to undergo an MRI (magnetic resonance imaging)
- Inability to undergo ionic radiation therapy and electroconvulsive therapy
- Implant-area infection
- Infection of the membrane covering the brain
- Personal Injury to the facial nerve, which can cause movement problems in the face
- Insufficient hearing results
- Localized inflammation
- Loss of residual hearing implant failure
- Numbness around the ear
- Permanent hearing loss
- Severe infection requiring implant removal
- Skin wound infections
- Cerebrospinal fluid leakage
- Surgical site blood and fluid collection
- Surgery-related perilymph fluid leakage
- Nerve damage-related taste disturbances following surgery
- Tinnitus (ringing or buzzing sound in the ears)
- Total loss of natural hearing caused by damaged cochlea cells
- Vertigo or dizziness
Some data reveals that cochlear implant patients, especially children, have unnecessary health risks for life-threatening bacterial meningitis and potentially fatal spinal cord swelling or brain. In addition, there may be additional risks, depending on the patient's medical condition.
Parents with young children who have undergone surgery should look for the signs of a defective device, including:
- Loss of hearing
- Pain or discomfort
- Unwillingness to use headphones
- Sudden loud noises and popping sounds
- Intermittent functioning
Many young children have experienced an electrical shock from their defective cochlear implants and have the trauma of undergoing replacement surgery on their implants.
The risk of reimplantation surgery is substantial, and with the removal and replacement of damaged electrodes, there is a risk of damaging the auditory nerve.
Surgical Cochlear Implant Procedure
Typically, the physician will perform cochlear implant surgery in a clinic or hospital. Usually, the surgery takes 2 to 4 hours to complete.
The process of the surgery:
- The surgeon makes an incision (cut) behind the deaf person's ear before opening the mastoid bone
- The physician locates the facial nerves in the mastoid bone, creating an opening between the nerves gaining access and opening the cochlea
- The surgeon inserts implant electrodes into the cochlea
- The doctor inserts the receiver (electronic device) behind the ear under the skin, securing it to the patient's skull
- The physician closes the incision
- The individual is usually discharged from the facility following two hours of close monitoring and observation
Defective Cochlear Implants
Many patients who have undergone an implant surgery have experienced a device malfunction, producing a wide array of complications, including:
- Intermittent implant functionality
- Vestibular (inner ear) balance issues
- Painful sensations in the ears
- Electrical shock
Advanced Bionics Corporation
In 2010, the FDA (Food and Drug Administration) recalled cochlear implants manufactured by Advanced Bionics Corporation after recipients experienced severe pain, shocking sensations, and loud sounds.
Problems with the Advanced Bionic devices occurred eight to ten days after initial implantation. Yet Advanced Bionics sold defective devices even though German surgeons warned them.
The FDA sued Advanced Bionics because they used a component in their cochalear implants that were not approved by the Administration. The "feedthrough assembly" component caused an excessive moisture problem.
Dr. Thomas Lenarz, Director of the Clinic for Ear, Nose, and Throat for the German Hearing Center in Germany and Switzerland, found defects and reported the problems to a Swiss journalist. The Hanover Medical School Director said, "body fluid penetrates at the point [on the device body] where the implant should transmit signals to the auditory nerve, which leads to short circuits that damage the device."
The court awarded $1 million in punitive damages to the FDA's Center for Devices and Radiological Health lawsuit against Advanced Bionics. Prolonged hearing degradation caused by the fluid entering the device led to failure because no hermetic seal was needed to prevent damage to the Advanced Bionics implant.
The cochlear implants manufactured by Advanced Bionics were recalled. However, the manufacturer continued to sell defective implants known to cause stimulation interruption and negatively affect device performance.
In 2019, the FDA recalled the MED-EL Cochlear System designed for profoundly and severely deaf people where a hearing aid was ineffective. The medical hearing device was recalled because the helium leak test results were not within the standard specification of cochlear devices.
The recall notes show that "an accumulation of excessive moisture may cause complete device failure. Should any discomfort or pain sensation be experienced, please stop immediately using the device…."
Cochlear Implant FAQs
Our law firm understands that many families have unanswered questions concerning cochlear implant lawsuits when dealing directly with the insurance company. A medical malpractice lawyer has answered some of those questions below.
For additional information, contact our law office today at (888) 424-5757 (toll-free phone call) or use the contact form.
What Is the Success Rate of Cochlear Implants?
Statistically, patients who have undergone a cochlear device surgical procedure have a high success rate. In addition, many adults benefit significantly within the first few weeks after the surgery, however, adapting to hearing through an Advanced Bionics medical cochlear implant takes time.
The typical individual has maximally improved sound quality in the first three months following tuning sessions. Unfortunately, cochlear implant surgery has associated risks where the procedure could fail and not restore the patient's hearing.
Why Are Cochlear Implants Bad?
After FDA approval, cochlear implantable medical devices have helped tens of thousands of individuals improve the quality of their hearing. But unfortunately, cochlear implant defects are more permanent as inserting cochlear implants destroys the individual's residual hearing in the ear receiving the implant.
Like all surgeries, cochlear implant surgery has inherent surgical risks. However, complications are rare and usually include infections, bleeding, tinnitus (auditory nerve ringing in the ear), facial nerve weakness, dizziness, and substandard hearing. In some cases, the cochlear implant malfunctioned.
A German newspaper reported in November 2021 that doctors in Germany and Switzerland discovered defective medical devices in half of the cochlear implant devices made by Advanced Bionics.
Advanced Bionics continued to sell older defective implants. By February 2020, Advanced Bionics recalled some of its products, including the HiRes implants. Victims can now file a cochlear implant claim to compensate for damage
How Much Does It Cost to Get A Cochlear Implant?
Usually, insurance covers nearly all patients that undergo implant procedures that typically range between $30,000 and $50,000 on average. In addition, Medicare, Medicaid, and Veterans Affairs cover corrective surgery, while some insurance providers only cover a portion.
There will be additional costs in time to replace the implant's components, including magnets, microphones, and future repairs. However, insurance plans usually cover these costs.
Does An Individual Normally Hear with A Cochlear Implant?
Undergoing a cochlear device surgical implant procedure to overcome permanent hearing loss is a lifelong commitment. The fully implantable auditory hearing device might not improve the patient's hearing.
Cochlear implants do not restore normal hearing but help individuals with sounds. The device can be highly effective when hearing alarms, doorbells, telephones, and human speech.
After the surgical intervention, an expected failure rate of less than one percent might lead to having the implant removed to undergo replacement surgery.
Who are Potential Cochlear Implant Surgery Candidates?
Typically, an audiologist or health care provider will recommend a cochlear implanted receiver to patients experiencing hearing loss who usually rely heavily on lip-reading. Potential candidates for the implant surgery include:
- Implant recipients experiencing severe hearing loss where hearing aids are ineffective
- People whose hearing has poor clarity in both ears and are hard of hearing
- Adults and children who miss at least half or more spoken words without lip-reading while wearing hearing aids.
- Individuals who wear hearing aids that rely heavily on lip-reading
In many cases, people with moderate hearing loss will use partially inserted cochlear implants to preserve their hearing while simultaneously wearing a hearing device in the same ear. However, significant hearing loss might require a fully inserted implant to achieve maximum hearing through an electronic Advanced Bionics hearing device.
The results of cochlear implants vary significantly between individuals. However, many patients benefit enormously from the heightened awareness of sounds within the first days after surgery. Typically, the surgeon turns the implant on approximately 4 to 6 weeks after the procedure.
Patients should consider an implant early on because the ability to improve their hearing loss decreases significantly over time. However, with successful surgery, rehabilitation and therapy, patients could improve their hearing by:
- Understanding speech without lip reading
- Receiving varying sounds like phones ringing, doors closing, and footsteps
- Understanding voices over electronic devices, including smartphones
- Watching TV without needing closed captioning
- Hearing music
Personal Injury Attorneys Resolving Defective Cochlear Implant Claims
Were you or a loved one harmed by a defective cochlear implant? Did the FDA (Food and Drug Administration) recall your defective device that has caused your pain, discomfort, or physical harm?
Our product liability attorneys at Rosenfeld Injury Lawyers, LLC can hold those responsible for causing your injuries financially and legally accountable. Let our team file a cochlear implant lawsuit and sue the manufacturer or physician on your behalf.
Our team has access to a network of medical professionals and social workers who can help families cope with their loved one's birth injuries and an award-winning team of Chicago birth injury attorneys with a proven track record of success.
Many cochlear implant lawsuits have already been resolved through million-dollar settlements to ensure families have sufficient financial compensation for providing all the treatment and care the injured victim requires.
Contingency "No Win, No Fee" Guarantee
Call our product liability law offices toll-free at (888) 424-5757 to schedule a free consultation for immediate legal advice.
We accept all defective cochlear implant claims with a "No Win/No-Fee" guarantee, meaning if our defective cochlear implant law firm cannot obtain compensation on your behalf, you owe our legal team nothing.
All confidential or sensitive information you share with our law office will create an attorney-client relationship to ensure your privacy.