Advanced Bionics Cochlear Implant Lawsuits and Recalls

Advanced Bionics cochlear implant lawsuits currently center on the company’s HiRes Ultra and HiRes Ultra 3D devices, which were pulled from the market in February 2020 after body fluid began seeping into the electrode area and degrading recipients’ hearing. Recipients in the U.S. have filed product liability claims, Canadian class actions are moving forward in Ontario and Quebec, and Advanced Bionics separately paid more than $12 million in 2022 to resolve federal False Claims Act allegations tied to its external sound processors. A parallel wave of litigation over an earlier device, the HiRes 90K, produced a $7.25 million jury verdict in 2013 and hundreds of millions in Sonova reserves before most cases settled.

The 2020 Recall That Triggered Most Current Suits

On February 17, 2020, Advanced Bionics initiated a voluntary field corrective action for the first-generation HiRes Ultra and HiRes Ultra 3D cochlear implants. The FDA classified it as a Class 2 recall covering 8,159 units with lot numbers between 1,000,000 and 1,999,999, and listed the cause as “Device Design.”¹ Advanced Bionics reported at the time that more than 16,000 people had received the affected devices.² The FDA terminated the recall on January 26, 2023.

The failure mode was fluid ingress at the electrode lead. Body fluid seeped into the electrode pocket, creating conductive connections between electrode leads and causing short circuits. The hermetic seal of the implant case itself stayed intact, so the devices did not shut off entirely. Recipients experienced distorted sound quality, impaired speech comprehension, drops in electrode impedance, and in some cases needed higher current levels to hear at a comfortable volume.³ Advanced Bionics withdrew the first-generation devices worldwide and later introduced redesigned V2 versions.⁴

How Often the Devices Have Failed

Advanced Bionics’ initial estimate was that fewer than 0.5% of affected recipients had been explanted for the identified issue.² Independent clinical data have run much higher. Researchers at Hannover Medical School tracked 349 recalled devices and found that 181 (51.9%) showed anomalies tied to the fluid-ingress failure. By March 2022, 121 devices (34.7%) had been surgically removed. The median time before anomalies appeared was about 1,062 days.³

A separate retrospective study of 308 devices identified 65 failures (21.1%) by September 2021, with 63 directly attributable to the recall issue. That study estimated the ongoing failure rate at roughly 6% per year overall and 8% per year in pediatric recipients, with four-year cumulative device survival at 76.0%, well below the 92.6% figure Advanced Bionics reported globally.⁵

For patients whose implants failed, speech recognition scores dropped sharply before revision surgery. One study measured an average decline of 15.2 percentage points for word recognition and 27.3 points for sentence comprehension in quiet environments. About 82.5% of patients with confirmed failures underwent revision surgery, and most recovered their prior hearing levels within three months of reactivation, though the process required another operation with risks of cochlear fibrosis and a period without access to sound.⁵

Wieder v. Advanced Bionics: What U.S. Plaintiffs Can Still Claim

Wieder v. Advanced Bionics LLC, filed in the Southern District of New York, is the most closely watched U.S. product liability case arising from the recall. The plaintiffs, parents of a child identified as L.W., alleged that a HiRes Ultra 3D implant malfunctioned due to a defectively sealed “ring ground electrode” that let fluid in, requiring surgical removal.⁶

The family originally sued in 2022. That case was dismissed without prejudice after a tolling agreement, and they refiled in 2024 (Case No. 24 Civ. 8495) with a nine-count complaint asserting manufacturing defect, design defect, breach of implied warranty, violations of New York consumer protection law, fraud, failure to warn, negligence, and loss of services.⁶

Advanced Bionics moved to dismiss on federal preemption grounds. Cochlear implants are Class III medical devices that go through the FDA’s premarket approval process, and the Medical Device Amendments bar state-law claims that would impose requirements different from federal ones. In November 2025, Magistrate Judge Gabriel W. Gorenstein recommended dismissing most of the plaintiffs’ claims. The design defect claim was described as “squarely preempted” because it challenged the FDA-approved design itself. The manufacturing defect claim was found too conclusory to survive because the plaintiffs did not identify specific federal manufacturing standards that were violated.⁶

On March 31, 2026, District Judge Dale E. Ho adopted nearly all of the magistrate’s recommendations. Six of the nine counts were dismissed, including all the “classic product-liability theories”: manufacturing defect, design defect, implied warranty, consumer protection, fraud, and failure to warn. Three negligence-based counts and derivative loss-of-services claims survived because Advanced Bionics had not challenged them on preemption grounds. The court denied further leave to amend and directed the parties into discovery.⁷

The practical takeaway for anyone considering a U.S. lawsuit: preemption narrows the available theories to a thin band of claims tied to violations of existing federal requirements, not broader challenges to a device’s approved design or labeling. A viable complaint generally needs to plead a specific federal manufacturing standard the company allegedly violated, rather than argue in general terms that the device should have been designed differently.

Canadian Class Actions

Two class actions are moving forward in Canada. A statement of claim was filed in Toronto on April 27, 2023 on behalf of persons in Canada (excluding Quebec) who received Advanced Bionics HiRes Ultra and HiRes Ultra 3D implants. The proposed class is represented by Gluckstein Lawyers and Waddell Phillips LLP.⁸

A separate action was filed in Quebec by Troy Dingwell, a 77-year-old former Quebec resident who received his implant in 2017 and alleges it failed. Defendants include Advanced Bionics LLC, its parent companies Sonova Holding AG and Sonova AG, and the Canadian distributor Connect Hearing.⁹ The complaint alleges the V1 implants have a safety defect causing reduced performance, dizziness, vertigo, and seizures, and claims the devices were essentially a repackaged version of the previously recalled HiRes 90K without adequate new clinical testing.¹⁰ The Quebec Superior Court authorized the class action on February 27, 2025, and an official notice to class members was issued in May 2026. The case is in the pre-trial phase.¹¹

How the Earlier HiRes 90K Litigation Resolved

The 2020 recall was not Advanced Bionics’ first. In 2006, the company recalled its HiRes 90K Implantable Cochlear Stimulator due to excessive moisture that could leak into the devices, potentially causing failure and revision surgery.¹² About 4,000 devices implanted between 2003 and 2006 were affected, and Advanced Bionics later estimated up to half could eventually fail.¹³

In 2013, a Kentucky federal jury in Sadler v. Advanced Bionics awarded $7.25 million to a plaintiff whose HiRes 90K implant had a moisture seal defect that delivered electrical shocks causing convulsions. The jury found that the company had delayed revealing the defect to continue sales and included punitive damages. Advanced Bionics said it would appeal. After the verdict, Sonova increased its financial provisions for 90K-related claims by CHF 198 million, bringing the reserve to CHF 250 million, and stated it was “not prepared to go beyond this threshold.” Most explanted devices had been handled under warranty, and a substantial number of cases settled out of court.¹³

The FDA also pursued an enforcement action tied to the 2006 recall. Advanced Bionics had shipped devices without filing required supplemental information about a change in component supplier, so the FDA could not evaluate the safety impact. The company paid a $1.1 million civil money penalty, and then-CEO Jeffrey Greiner personally paid $75,000. Neither admitted liability.¹²

The $12 Million False Claims Act Settlement

In a separate track unrelated to the implant recalls, the U.S. Department of Justice announced on December 20, 2022 that Advanced Bionics would pay over $12 million to resolve allegations that it submitted false claims to federal healthcare programs. The case involved the company’s Neptune and Naida external sound processors rather than the implants themselves.¹⁴

The action began as a whistleblower lawsuit by David Nyberg, a former principal RF electrical engineer at Advanced Bionics from December 2010 to August 2017. Nyberg alleged that the company manipulated radio-frequency emissions tests to obtain FDA approval. According to his complaint, engineers used custom shielded enclosures to block RF emissions during testing, operated devices at artificially low power settings or with transmitters turned off, used abnormally short RF cables, and hand-selected prototype units with the lowest emission signatures.¹⁵ The processors allegedly could not pass required international emissions standards under normal conditions, yet the company represented to the FDA that they did. Because the FDA approvals enabled reimbursement from Medicare, Medicaid, TRICARE, and other government programs, the false testing results allegedly made those reimbursement claims fraudulent.¹⁴

Advanced Bionics paid approximately $11.36 million to the federal government and $1.24 million to participating state Medicaid programs. Nyberg received roughly $1.87 million as a whistleblower share.¹⁶ The settlement resolved allegations only, with no determination of liability. Advanced Bionics also entered a five-year Corporate Integrity Agreement with the HHS Office of Inspector General, effective December 19, 2022 and running through roughly December 2027. The agreement requires independent review of the company’s processes for preparing and submitting premarket approval applications to the FDA, plus risk assessments and compliance certifications from management and the board.¹⁷

What Isn’t a Consumer Lawsuit

One high-profile Advanced Bionics dispute is not a patient case. The company and Austrian competitor MED-EL fought a multi-front patent war over MRI-safe magnets and signal-processing technology across the U.S. International Trade Commission, the Federal Circuit, Germany, the Netherlands, the UK, and the European Patent Office.¹⁸ The parties reached a global settlement in July 2025 to withdraw all patent litigation, on undisclosed terms.¹⁹ The dispute concerned competitor patent rights, not device safety, and did not involve claims from implant recipients.

1
FDA. Recall Detail – Z-2032-2020
2
FDA. Voluntary Field Corrective Action – HiRes Ultra and Ultra 3D
3
Wiley Online Library. Failure Pattern of the HiRes Ultra and Ultra 3D Cochlear Implant
4
Advanced Bionics. AB Reliability Report
5
National Library of Medicine. Recall-Related Failures of the HiRes Ultra Cochlear Implant
6
FindLaw. Wieder v. Advanced Bionics LLC
7
PacerMonitor. Wieder et al v. Advanced Bionics LLC
8
Gluckstein Lawyers. Cochlear Implant Class Action
9
Trudel Johnston & Lespérance. Defective Advanced Bionics Cochlear Implants
10
Trudel Johnston & Lespérance. Dingwell v. Advanced Bionics – Application for Authorization
11
Registre des actions collectives du Québec. Dingwell v. Advanced Bionics, No. 500-06-001254-230
12
MDDI Online. Advanced Bionics Reaches $1.1 Million Settlement With FDA
13
Sonova. Advanced Bionics Will Appeal Cochlear Implant Verdict
14
U.S. Department of Justice. Advanced Bionics LLC to Pay Over $12 Million for Alleged False Claims for Cochlear Implant Processors
15
ClassAction.org. Nyberg v. Advanced Bionics Corp. – First Amended Complaint
16
U.S. DOJ – Eastern District of Pennsylvania. Advanced Bionics LLC to Pay the United States $11.36 Million to Resolve FCA Allegations
17
HHS Office of Inspector General. Corporate Integrity Agreement – Advanced Bionics LLC
18
JUVE Patent. MED-EL and Advanced Bionics Settle Shortly Before Mannheim UPC Judgment
19
U.S. International Trade Commission. Certain Cochlear Implant Systems and Components Thereof, Inv. 337-1418