When a child is born with hearing complications — either hard of hearing or profoundly deaf — his parents may feel intense distress and grief. They may feel like they have to “fix” their precious little one, and they will be willing to do anything in service of this goal. It’s during this time that many parents rush to the cochlear implant.
The cochlear implant has been changing the lives for people with hearing impairments since 1972. To many, they seem like a miracle. We’ve all seen the viral videos: a baby becomes overjoyed at hearing his mother’s voice for the first time, an adult weeps upon hearing again after decades of silence. It’s no wonder that so many people – 58,000 adults and 38,000 children, according to the National Institute on Deafness and Other Communication Disorders (NIDCD) – have elected to receive a cochlear.
However, it is important to remember that cochlear implants, like all surgeries, are never without risk. In fact, the cochlear has had a long history of recalls, complications, and lawsuits over the past four decades. If you are considering a cochlear implant for yourself or a loved one, here are a few things you need to know.
What is a Cochlear Implant?
Cochlear implants are designed for individuals with severe hearing loss, for whom devices such as hearing aids would be ineffective. Unlike hearing aids, which merely amplify sound around a person, a cochlear implant works to bypass the ears, delivering sound directly to the auditory nerves in the cochlea, or inner ear. This allows sound to reach the brain, restoring the ability to hear.
When a person receives a cochlear implant, a surgeon gives them a small incision just behind the ear. He or she then located the cochlea, opens it, and inserts an electrode. This will allow the recipient to hear once again. Then, the doctor installs a small, circular receiver by affixing it to the skull. This will pick up sound and send information to the electrode.
A typical cochlear implant procedure takes around two hours per ear and is generally considered an outpatient procedure. The surgeon will use local anesthesia and send the patient home after a few hours of observation. However, this is when the journey truly begins: learning to use a cochlear implant is often a long process that requires weeks or even months of work with speech therapists and audiologists. But eventually, the individual will be able to hear again and live their life as normal.
Because cochlear implants take a long time to learn how to use effectively, many doctors recommend getting the implant as soon as possible. In fact, Johns Hopkins claims that “early intervention is key,” even saying that “Opportunity for improvement decreases over time as hearing loss worsens.” This news can be worrisome to new parents and might drive them to make rash decisions in the service of their child. Before a parent hurries to give their child a cochlear implant, they should fully understand the risks of this procedure.
Risks and Complications
Like all surgical procedures, a cochlear implant comes with its fair share of risks and side effects. Most doctors agree these side effects are rare; a 2015 study in the Journal of Life and Medicine, which looked at cochlear implant patients at the Emergency Hospital for Children in Bucharest, Romania found that complications occurred in about 8.86% of implant recipients. Stanford Health Care cites the following as the most common side effects of cochlear implants:
- Fluid leakage (particularly around the brain or inner ear)
- Device malfunction
- Facial nerve weakness
- Tinnitus (ringing in the ear)
- Poor hearing result
Additionally, some individuals who receive cochlear implants have suffered from meningitis. Stanford Health Care states that 91 cases out of 60,000 patients with cochlear implants have developed the infection because of their surgery – and 17 of those individuals have died. While the risk of meningitis is rather low, individuals should be aware of this risk before agreeing to receive a cochlear implant.
There are also complications that can develop during the learning phase of the device. For example, many implant patients have reported hearing “mechanical” or “synthetic” sounds after receiving the implant in place of the natural sounds they used to hear. This complaint is more common in individuals who experience hearing loss later in life (as opposed to those born deaf or hard of hearing), and the FDA reports that most users stop noticing this issue after a few weeks.
Other complications associated with cochlear implant use include:
- Loss of residual hearing
- Implant failure
- Inability to have MRIs, electroconvulsive therapy, or ionic radiation therapy in the future
- The device can be damaged by static electricity
- External parts cannot get wet
A Controversial Surgery
In addition to the medical risks associated with cochlear implants, this surgery is very controversial among members of the Deaf community. Deaf people have a thriving culture within the United States, with its own language, social norms, and tight-knit community. Many deaf individuals take pride in this cultural identity, and do not view their deafness as a disability to be “fixed.”
Of course, the cultural aspect of deafness is rarely discussed when a child is born with hearing loss – especially if that child is born to hearing parents. Many hearing parents resort to cochlear implants to restore their child’s hearing because they don’t know of any other options. Cochlear implants can be useful to individuals who want to regain the ability to hear, but – as many deaf advocates insist – it is not the only way for a deaf person to be happy.
The decision of whether to give a child a cochlear implant can be agonizing, even before you factor in issues of disabilities vs. Deaf culture. The most extreme Deaf advocates argue that cochlear implantation – particularly on children who take no part in the decision-making process – is akin to “genocide” of their cultural group; medical professionals call in a miracle, and question whether refusing a child cochlear is child abuse. Ultimately, the decision will come down to the parents or guardians of the individual (or, if they’re old enough, the individual himself). Therefore, it’s best to be informed of all the options a person has available.
Cochlear Implant Lawsuits
With all this information on the risks, benefits, and controversies surrounding cochlear implants, let’s look at how the law has dealt with these procedures. Cochlear implants have been recalled by the FDA multiple times, and the companies that make them are not always forthcoming with their patients – which can have devastating effects.
In 2007, the FDA’s Center for Devices and Radiological Health sued cochlear manufacturer Advanced Bionics due to a new “feedthru assembly” component in their devices. This component had not received premarketing approval (FDA approval required before a device can go to market). Unbeknownst to patients, this new assembly was causing an excess of moisture that contributed to permanent hearing loss. The case was settled a year later, with Advanced Bionics paying over $1 million.
Advanced Bionics was also the defendant in a 2013 case in Kentucky, wherein an 11-year-old girl suffered electric shocks from a defective cochlear implant. The young lady – who had been born deaf – received her implant at the age of four; by the time she was eight, she was suffering electrical shorts that threw her to the ground. She ultimately had the implant removed in a seven-hour surgery, and Advanced Bionics was ordered to pay her family a staggering $7.25 million.
While cochlear implants can radically change the lives of people experiencing hearing loss, it is critical that these individuals know the potential risks involved in the procedure. Additionally, individuals should have sound legal counsel in their corner if something goes wrong. TorkLaw attorneys are award-winning legal professionals who truly care about their clients, and they are always ready to fight for individuals who need it.
If you or a loved one is suffering from complications following a cochlear implant procedure, contact us today to learn how we can help.