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March 2, 2023

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Are you or your child victims of medical malpractice where the doctor’s negligence led to a cochlear implant mistake? Did the 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 lawsuits 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 product liability attorneys at (888) 424-5757 (toll-free phone call) or use the contact form today to schedule a free consultation related to a potential cochlear implant lawsuit.

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.

Cochlear Implant Lawsuit

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 Advanced Bionics cochlear implants.

Since 1972, many individuals with hearing impairments have undergone cochlear device surgery.

Data from the National Institute on Deafness and Other Communication Disorders (NIDCD) [1] 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, implants are not without risks. Patients with cochlear implants have faced an extensive history of severe complications for decades.

The manufacturer had faced implant recalls and 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 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) [2].

Bypassing the eardrum 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 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 device, the doctor will likely discuss specific facts about the procedure and what to expect in the days, weeks, and months following the surgical operation.

The particular facts include:

  • The therapy will teach the individual how to interpret electrical signals to understand aural and 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, [3] or being involved in an accident that 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 maintain their natural hearing ability.

lawyer for cochlear implant injuries

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
  • 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
  • Personal Injury to the facial nerve, which can cause movement problems in the face
  • Insufficient hearing results
  • Localized inflammation
  • Loss of residual hearing cochlear implant failures
  • Numbness around the ear
  • Permanent hearing loss
  • Severe infection requiring implant removal
  • Skin wound infections
  • Cerebrospinal fluid leakage
  • Surgical site blood and fluid collection
  • Surgical-related perilymph fluid leakage
  • Swelling
  • Nerve damage-related taste disturbances following surgical operation
  • Tinnitus (ringing or buzzing sound in the ears)
  • Total loss of 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.

In addition, there may be additional risks, depending on the patient’s medical condition.

Parents with young children who have undergone surgical resection 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 are traumatized by 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 for cochlear implant processors 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
  • After two hours of close monitoring and observation, the individual is usually discharged from the facility

Defective Cochlear Ear Implants

Many patients who have undergone implant surgery [4] have experienced a device malfunction, producing a long history of complications with the medical devices, including:

  • Intermittent implant functionality
  • Vestibular (inner ear) balance issues
  • Painful sensations in the ears
  • Electrical shock
  • Generate RF emissions that potentially interfere with security systems and other devices using the radio frequency spectrum

Advanced Bionics Corporation: Cochlear Implant Recall

The Food and Drug Administration recalled cochlear implants manufactured by Advanced Bionics Corporation in 2010 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 coch­lear implants without the Administration’s premarketing approval. The “feed-thru 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 electrical 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.

Advanced Bionics supposedly claimed that its processors met an internationally recognized emissions standard. However, in reality, Advanced Bionics failed to adhere to that standard.

Med-El vs Cochlear vs Advanced Bionics

In 2019, years after FDA Approval, the government agency 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….”

Class action lawsuits against Advanced Bionics and Cochlear Limited regarding their cochlear implants were filed.

In 2007, the FDA sued Advanced Bionics for failing to obtain premarketing approval, leading to device failures and potential hearing loss. The case was settled for over $1 million.

In a separate incident, a Kentucky jury awarded $7.25 million to a young girl who suffered severe harm from an Advanced Bionics device.

Cochlear Limited faced a class action lawsuit for implants that failed due to manufacturing flaws, affecting thousands of patients worldwide.

They settled with the US Department of Justice for $880,000. These cases highlighted the companies’ profit-driven actions over patient safety.

Personal Injury Attorneys Resolving Defective Cochlear Implant Lawsuits

Were you or a loved one harmed by a defective Advanced Bionics HiRes Ultra or HiRes Ultra 3D Cochlear Implantable Device? 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 civil 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 successful outcomes.

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 an experienced attorney toll-free at (888) 424-5757 to schedule a free consultation for immediate legal advice.

We accept all defective cochlear ear 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.

Resources: [1] NIDCD, [2] NIH, [3] NIH, [4] NIH

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