Advanced Bionics Lawsuits for Cochlear Implant Failures

Attorneys working with ClassAction.org are investigating whether lawsuits can be filed against Advanced Bionics over its HiRes Ultra and Ultra 3D cochlear implants.

Reports have surfaced that certain versions of the devices may be failing at alarming rates, requiring revision surgery to remove and replace the implant. Now, attorneys are looking into whether a defect is to blame and, if so, whether patients can file lawsuits against the manufacturer for medical bills, psychological injuries and more.

Advanced Bionics 2020 Cochlear Implant Recall: What Happened?

In early 2020, Advanced Bionics announced that it would be initiating a field corrective action for its HiRes Ultra and Ultra 3D cochlear implants due to an increasing number of reports of hearing degradation and revision surgeries.  

Specifically, the company stated that some patients had experienced performance issues stemming from body fluid entering the electrode, which could hamper the functionality of the device.

As part of the recall, Advanced Bionics pulled all unimplanted initial versions of the HiRes Ultra and Ultra 3D from the market and warned that those experiencing problems with the devices could require revision surgery to remove the old implant and replace it with an updated version.

While the company maintained at the time that less than 0.5% of recipients needed the implant removed, one study performed by world-renowned Swiss otolaryngologist Thomas Lenarz found a shocking failure rate with the devices.  

Of the 349 patients who had been implanted with the HiRes Ultra and Ultra 3D cochlear implants at his institution in Germany, more than 50% had experienced problems as described by Advanced Bionics’ recall. Around 35% of these patients had already had their devices removed, with the study finding that the median time between implantation and the development of potential failure-related performance issues was less than three years.

Cochlear Implant Failure: What Are the Symptoms?

The letter stated that patients experiencing these symptoms should see their audiologist for a hearing assessment and reprogramming of the device, noting that those who cannot have the issue resolved may require revision surgery.

It’s believed that adult patients who suffer gradual hearing loss may get used to an inferior level of performance and wrongly assume that their hearing isn’t going to get any better, accepting impaired function as the new normal. Other individuals may make frequent visits to the audiologist for testing and reprogramming of the implant only to later find that it has failed and will need to be replaced.

Attorneys suspect that, in children, problems with the device may be especially difficult to detect as the brain is still developing and inferior performance could become normalized. Should the implant fail in a pediatric patient, immediate revision surgery may be necessary to reduce any damage to the language development process.

What’s Involved in Filing a Lawsuit?

Before filing a lawsuit, your attorney will need to gather information from you, along with relevant medical records, to help build your case. They may ask when and how you discovered a problem with the implant, the steps needed to determine the device had failed, details regarding the revision surgery, and how failure of the implant affected the recipient’s life.

Once the appropriate information has been gathered, your attorney will draft what’s known as a complaint, a document outlining the damages you are seeking and the allegations you are making against the defendant – that is, the company being sued. For instance, your lawsuit could allege that Advanced Bionics allowed a defective product into the marketplace, knew or should have known about the risks associated with its implants, delayed in warning both patients and doctors, and is now responsible for the harm caused to you or your child.  

Once your complaint is filed with the court, your lawsuit has officially begun. From there, your attorney will engage with the defendant’s representation, as well as the court, in an attempt to resolve the matter. The attorneys may exchange documents, file motions with the court, take depositions, consult with medical experts and more.

If the lawsuit is not dismissed or settled, it may proceed to a jury trial, though those are becoming increasingly rare in civil cases.

Even if you are unsure which implant was used, if you or your child experienced failure with a cochlear implant, an attorney can help confirm the medical device used in the procedure.

What Could I Get From a Lawsuit?

Is This a Class Action?

No. Attorneys working with ClassAction.org have decided to handle this matter on an individual basis – and not as a class action lawsuit. This is because they believe Advanced Bionics patients have suffered injuries serious enough to warrant individual cases, whereas class action lawsuits typically seek relief for less severe harm. Click here for more information on why cases involving medical devices are not typically handled as class action lawsuits.

Has Advanced Bionics Been Sued Before for its Cochlear Implants?

Advanced Bionics has recently been the center of a lawsuit brought on behalf of the U.S. government by a whistleblower who alleged the company misled Medicare, Medicaid and other government health programs about the radio-frequency emissions of some of its cochlear implant processors. Specifically, the case claimed 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.

In December 2022, the Department of Justice (DOJ) announced that it had reached a more than $12 million settlement with Advanced Bionics to put an end to the case.  

The company has also reportedly faced personal injury lawsuits over its HiRes 90K cochlear implant – a device that was also recalled due to a moisture problem and reportedly caused some patients to suffer “painful shocks to the head.” In one case, a Kentucky jury reportedly handed down a more than $7 million award for an eight-year-old girl who allegedly developed “severe electric shocks” in her head from the device.

How Much Will a Lawyer Cost?

Attorneys working with ClassAction.org are handling these cases on a contingency-fee basis – which means you only pay if they win. Their payment will come as part of your jury award or settlement. 

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