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 cochlear implant due to malfunction?

The personal injury attorneys at Rosenfeld Injury Lawyers, LLC can serve as your legal advocates for families filing defective cochlear implant claims. We can ensure you receive the total punitive damages and financial compensation for medical bills and other expenses you deserve.

Contact our defective medical device attorneys at (888) 424-5757 (toll-free phone call) or use the contact form today to schedule a free consultation. We treat all information you disclose with our law office as a confidential part of the attorney-client relationship to ensure your privacy.

Children born with partial or total hearing loss cause the parent's intense grief and distress knowing their child is profoundly deaf or hard of hearing. The parents want to help their children by offering life-changing opportunities, such as a cochlear implant.

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, implant recalls, and compensation lawsuits when their cochlear implants malfunctioned.

Cochlear Implants

Medical device manufacturers design cochlear implants for adults and children suffering severe hearing loss where a traditional hearing aid is ineffective. Unlike hearing aids, these devices do more than merely amplify sound like a hearing aid but instead deliver sound directly to the patient's auditory nerve in the inner ear (cochlea).

Bypassing the ears and sending auditory 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.

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 missing at least half or more of all spoken words without lip-reading while wearing hearing aids or not
• 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 aid in the same ear. However, significant hearing loss might require a fully inserted implant to achieve maximum hearing through an electronic medical 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.

Individuals tend to understand speech gradually, maximizing their hearing and understanding in the first six months. Usually, the patient requires rehabilitation and therapy after surgery to maximize their benefits.

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

Preparing for Cochlear Implant Surgery

A cochlear medical device does not restore the patient's hearing to normal. In addition, in a small number of cases, the surgery does nothing to help the individual's hearing.

While recommending a cochlear medical 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:

• Individuals who have undergone the implant surgery will need training and therapy that teaches how to care for the device
• 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 in 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.

The potential candidate must undergo a physical examination and hearing tests and meet with a counselor or psychologist. Also, potential candidates are typically assessed by a speech-language pathologist, audiologist, and otologist (doctors that provide medical treatment for hearing-related disorders).

Cochlear Implant 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
• Bleeding
• 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
• 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
• Swelling
• 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
• Crying
• 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 individual is usually given general anesthesia to ensure they are asleep during the surgery.

In 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 nursing staff removes the individual from the operating room to the recovery area for close monitoring
• The individual is usually discharged from the facility following two hours of close monitoring and observation

Typically, it takes approximately four to six weeks after the surgery to heal completely. At that time, the physician will add the external implant parts, including the speech processor and microphone.

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) issued a recall to the Advanced Bionics Corporation for the Advanced Bionics cochlear implants after recipients experienced severe pain, shocking sensations, and overly loud sounds.

Problems with the Advanced Bionics device occurred 8 to 10 days after initial device activation. Yet Advanced Bionics continued to sell defective implants despite warnings from German surgeons, according to researchers.

In 2007, the FDA sued Advanced Bionics for using a component in their cochlear implants that did not receive the FDA-required premarketing approval. The "feedthru assembly" component caused an excessive moisture problem.

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."

The court awarded $1 million in punitive damages to the FDA's Center for Devices and Radiological Health lawsuit against Advanced Bionics. Although Advanced Bionics recalled the devices, implants were still shipped and implanted after the recall.

In 2013, the family of an 11-year-old girl in Kentucky won a $7,25 million lawsuit from Advanced Bionics for suffering electric shocks from her defective cochlear implant. She received her implant at four, and by the time she was eight, she suffered electrical shorts that threw her to the ground.

MED-EL

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 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 internal moisture may cause complete failure of the device. 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.

Personal Injury Attorneys Representing Defective Cochlear Implant Lawsuits

Were you or a loved one harmed by a defective cochlear implant? Did the FDA (Food and Drug Administration) recall your device that has caused your pain, discomfort, or physical harm?

At Rosenfeld Injury Lawyers, LLC, our injury attorneys 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 medical malpractice cases 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 law firm today at (888) 424-5757 (toll-free phone number) to schedule a free consultation for immediate legal advice. We provide every client a "No Win/No-Fee" Guarantee, meaning if we cannot obtain compensation on your behalf, you owe our legal team nothing.

Additionally, all confidential or sensitive information you share with our law office will create an attorney-client relationship to ensure your privacy.

Resources:

• Johns Hopkins Medicine – Cochlear Surgical Procedure
• FDA – A Medical Device Recall
• Food and Drug Administration – About Cochlear Medical Device