Cochlear implant lawsuits have largely centered on device failures at two manufacturers: Advanced Bionics, whose HiRes 90K and HiRes Ultra implants were recalled after moisture entered the sealed device and caused shocks, distorted sound, and forced revision surgery, and Cochlear Limited, whose Nucleus CI500 range was recalled in 2011 for similar failures. Plaintiffs have won a $7.25 million jury verdict, secured a $1.1 million FDA penalty against Advanced Bionics, and filed active class actions in Canada. A separate $12 million False Claims Act settlement in 2022 resolved unrelated allegations that Advanced Bionics misled federal health programs about processor emissions.
What These Lawsuits Are About
The recurring claim is that a sealed implant let moisture reach its electronics, and that the manufacturer knew about the defect before patients or clinicians did. In the HiRes 90K, the failure was traced to hermetic seals from a supplier called AstroSeal, which produced a “feed-through” component connecting the internal circuitry to external parts. Advanced Bionics switched to AstroSeal without notifying the FDA or seeking supplemental approval, and the agency later considered the affected devices “adulterated” under federal law.1MD+DI Online. Advanced Bionics Reaches $1.1 Million Settlement With FDA
Recipients of failing devices have reported severe pain, overly loud sounds, and shocking sensations after activation, followed by surgical removal and replacement.2FDA. Class 2 Recall Advanced Bionics HiRes 90K Cochlear Implant Suits have been brought under standard product liability theories: design defect, manufacturing defect, failure to warn, negligence, and breach of warranty, with punitive damages sought where plaintiffs allege the company kept selling a device it knew was defective.
The Sadler v. Advanced Bionics $7.25 Million Verdict
The highest-profile personal injury verdict came in April 2013, when a federal jury in the Western District of Kentucky awarded $7.25 million to the family of Breanna Sadler, who received a HiRes 90K implant in 2006 at age four. In 2010 the device shocked her three times; one episode threw her to the ground and caused vomiting and convulsions. She described her face feeling like it was “melting” or “on fire.”3USA Today. Cochlear Implant Case Award
After the implant was disconnected, Breanna spent six weeks in total deafness before a seven-hour surgery to remove the device and replace it with a competitor’s model. Testing of the explanted device found 38.57% moisture content, far above the FDA’s 0.5% limit.4MassDevice. Jury Hits Advanced Bionics With $7M Judgment Over Recalled HiRes 90K Cochlear Implant
The jury, before Senior Judge Thomas Russell, found the device “negligently designed, defective and unreasonably dangerous.” It awarded $6.25 million in punitive damages, concluding that Advanced Bionics continued to sell the device despite knowing it was leaking in order to protect profits and sales-based bonuses. The remaining $1 million covered medical expenses, pain and suffering, lost wages, and travel costs. The jury also found the company had failed to inform the FDA about its switch to the AstroSeal supplier.3USA Today. Cochlear Implant Case Award
Advanced Bionics said it disagreed with the verdict. Sonova CEO Lukas Braunschweiler said the company would appeal and was “prepared to vigorously challenge any future cases.”5Hearing Review. Advanced Bionics Will Appeal Kentucky Court Verdict The final outcome of any appeal is not in the public record reviewed here.
Other HiRes 90K suits followed. Scott and Pamela Purcel sued in the Northern District of Texas in September 2007 on behalf of their son, naming both Advanced Bionics and AstroSeal. A federal judge allowed the case to proceed, finding preemption did not bar the claims because they rested on violations of federal law rather than state-law rules that differed from the FDA’s.6MPO Magazine. Preemption Not Issue in Cochlear Implant Suit A Missouri case involving a seven-year-old plaintiff settled for $152,000, and by 2013 most of the HiRes 90K personal injury litigation had resolved through what one legal summary called “significant settlements.”7Miller & Zois. Cochlear Implant Lawsuits
HiRes 90K Recalls and the $1.1 Million FDA Penalty
The device history behind those cases is a chain of recalls. Advanced Bionics recalled unimplanted HiRes 90K devices containing AstroSeal feed-throughs in September 2004, and according to one lawsuit knew by October 2004 that implanted devices were leaking without notifying clinicians or patients.8Courthouse News Service. Parents Call Hearing Aid Maker Reckless A larger voluntary recall in November 2010 pulled the HiRes 90K from the market entirely after two confirmed malfunctions required surgical removal; the company reported more than 28,000 devices had been implanted worldwide.9FiercePharma. Advanced Bionics Announces FDA Approval for U.S. Market Re-Entry of HiRes 90K Cochlear Implant The FDA approved the device’s return in September 2011 after manufacturing changes.10Sonova. Sonova Announces FDA Approval for U.S. Market Re-Entry of Advanced Bionics HiRes 90K Cochlear Implant
In July 2008, Advanced Bionics paid a $1.1 million civil penalty to the FDA, the maximum then allowed, for shipping cochlear implants without filing supplemental information about the supplier change. Then-CEO Jeffrey Greiner separately paid $75,000. Neither admitted liability. The FDA alleged that in at least two instances devices containing the unapproved AstroSeal components were implanted in patients after the 2004 recall had begun.1MD+DI Online. Advanced Bionics Reaches $1.1 Million Settlement With FDA
HiRes Ultra: The Current Litigation Wave
A newer generation of Advanced Bionics devices produced a similar problem. On February 18, 2020, the company recalled the initial (“V1”) versions of the HiRes Ultra and HiRes Ultra 3D after reports of fluid entering the electrode area, causing impedance drops, degraded sound, and declining speech comprehension. The V1 devices, identifiable by serial numbers starting with “1” followed by six digits, were withdrawn from sale worldwide.11Wiley Online Library. HiRes Ultra Cochlear Implant Recall Study
The failure numbers are unusually high. Advanced Bionics’ own reliability data, published in July 2025, shows cumulative removal rates of 34.14% at eight years for HiRes Ultra V1 and 34.02% at six years for HiRes Ultra 3D V1, with device failure accounting for most removals.12Advanced Bionics. AB Reliability Report Analysis of 80 explanted devices confirmed electrode shorts caused by fluid ingress in 76 cases.11Wiley Online Library. HiRes Ultra Cochlear Implant Recall Study A Vanderbilt University Medical Center study of 308 V1 devices in 254 patients found 65 confirmed failures (21.1%), with an average time to failure of 2.2 years and a four-year survival rate of only 69% in pediatric patients. The researchers noted their observed failure rate was substantially higher than the manufacturer’s reported 92.6% four-year survival, suggesting hard failures may be underreported.13National Library of Medicine. Vanderbilt Study on AB HiRes Ultra V1 Failures
Redesigned V2 devices show far lower removal rates: 0.62% at four years for the HiRes Ultra V2 and 1.78% at five years for the HiRes Ultra 3D V2, with device-specific failure rates below 0.15%.12Advanced Bionics. AB Reliability Report
Canadian Class Actions
In Quebec, a proposed class action filed on August 3, 2023, by Troy Dingwell against Advanced Bionics and affiliated companies was authorized by the Superior Court of Quebec on February 27, 2025. The class covers all Quebec residents implanted with V1 HiRes Ultra or HiRes Ultra 3D devices (serial numbers 1,000,000 to 1,999,999), along with their family members and caregivers. The suit alleges the devices contain a safety defect causing reduced performance and symptoms including dizziness, vertigo, and seizures, and that children who undergo revision surgery face risks of developmental and learning delays. It seeks compensatory and punitive damages.14Trudel Johnston & Lespérance. Defective Advanced Bionics Cochlear Implants
A companion class action covering the rest of Canada has been filed but not yet certified. Defendants’ materials are due in mid-2025, and the certification motion is scheduled for April 8–10, 2026.15Sotos Class Actions. Advanced Bionics HiRes Cochlear Implants
U.S. Federal Cases
In Wieder v. Advanced Bionics LLC, filed in the Southern District of New York over product liability and failure-to-warn claims, a magistrate judge recommended in November 2025 that most state-law claims be dismissed as preempted by federal law governing pre-market approved devices. In April 2026 the district judge adopted those recommendations and partially granted the motion to dismiss, though some claims survived.16Mealeys. Judge Trims Claims Against Manufacturer in Defective Cochlear Implant Case
The $12 Million False Claims Act Settlement
Separately from the device-defect cases, Advanced Bionics agreed on December 20, 2022, to pay more than $12 million to resolve allegations that it misled federal health care programs about the radio-frequency emissions generated by certain cochlear implant processors. The Department of Justice described the resolution as involving both civil and criminal components.17HHS Office of Inspector General. Advanced Bionics LLC To Pay Over $12 Million for Alleged False Claims for Cochlear Implant Processors
The underlying case, United States, et al., ex rel. Nyberg v. Advanced Bionics Corp., was brought under the False Claims Act’s whistleblower provisions in the Eastern District of Pennsylvania. Advanced Bionics also entered a five-year Corporate Integrity Agreement with the HHS Office of Inspector General. The settlement resolved allegations only; there was no determination of liability.18U.S. Department of Justice. Advanced Bionics LLC To Pay Over $12 Million for Alleged False Claims for Cochlear Implant Processors
Cochlear Limited and the Nucleus CI500 Class Action
In September 2011, Cochlear Limited, the Australian maker of the world’s most widely used cochlear implants, recalled its Nucleus CI500 range (CI512, CI513, ABI541, and CI551) after a rise in failures.19Therapeutic Goods Administration (Australia). Cochlear Nucleus CI500 Implant Range Recall Notice The root cause was traced to variations in the brazing process that produced microcracks, letting water reach electronic components. At least 25,516 units had been implanted in the United States, and by January 2012 the global failure rate stood at 2.4%. In April 2012, Wyly Wade filed a federal class action in Chicago on behalf of his daughter, who received the implants in June 2011 and required surgical removal by September 2011. The complaint alleged strict product liability, failure to warn, negligence, breach of warranty, and misrepresentation.20Courthouse News Service. Class Claims Cochlear Implants Fail The FDA classified the CI512 recall as Class 2, covering 33,645 units globally.21FDA. Class 2 Device Recall Cochlear Nucleus CI512 Cochlear Implant
Why Federal Preemption Often Decides These Cases
Because cochlear implants are Class III medical devices that go through the FDA’s pre-market approval process, manufacturers routinely argue that state-law tort claims are preempted by the Medical Device Amendments to the federal Food, Drug, and Cosmetic Act. The April 2026 ruling in Wieder is a recent example, dismissing most state-law claims on that ground.16Mealeys. Judge Trims Claims Against Manufacturer in Defective Cochlear Implant Case
Where a plaintiff can show the manufacturer violated FDA requirements rather than met them, courts have allowed claims to move forward. The Purcel case in Texas allowed the suit to proceed because it rested on Advanced Bionics’ failure to follow federal law when it used an unapproved supplier.6MPO Magazine. Preemption Not Issue in Cochlear Implant Suit That distinction, between claims that a device failed to meet the FDA’s own standards and claims that would impose additional state-level requirements, tends to decide whether a cochlear implant case reaches a jury.