Advanced Bionics Cochlear Implant Lawsuit | 2026 Latest Updates

Advanced Bionics cochlear implants face lawsuits over device failure and revision surgery. This includes the initial HiRes Ultra and Ultra 3D. Plaintiffs allege a design defect lets fluid seep into the electrode array, and that the company failed to warn. Individual product-liability suits have been filed in the United States, and an Ontario class action was certified on April 21, 2026. One New York suit, Wieder, settled and closed on August 13, 2026. No MDL has been formed. A separate 2022 False Claims Act settlement of more than $12 million concerned RF emissions testing of older Neptune and Naida processors.

Latest Advanced Bionics Cochlear Implant Lawsuit Updates

August 13, 2026: Wieder Settlement Approved and Case Closed

Magistrate Judge Gabriel W. Gorenstein of the Southern District of New York approved the settlement of the remaining claims in Wieder v. Advanced Bionics LLC. He directed the clerk to close the case [1]. The settlement amount is confidential. The parents, who sued for a child implanted in 2018, take no money. It is held for the child.

July 21, 2026: Ontario Court Cuts Class Action Costs by 50%

Law360 Canada reported that the Ontario Superior Court of Justice cut the costs the plaintiff requested for the Pedersen certification motion by 50%. The court cited mixed success, in a ruling numbered 2026 ONSC 4140 [2]. Justice E.M. Morgan had certified the national class on April 21, 2026, for patients with a hard device failure and revision surgery.

March 31, 2026: Court Dismisses Most Wieder Counts

Judge Dale Ho adopted in full a magistrate judge’s report in Wieder. He dismissed the defect, warranty, consumer-law, fraud and failure-to-warn counts as preempted or inadequately pleaded [3]. The negligence and loss-of-services counts went forward. They concern testing by the company’s representatives after the implant was placed in the child, and medical expenses.

March 5, 2026: FDA Posts Class 2 Recall for Sky CI M90 Processors

FDA published a Class 2 recall, Z-1493-2026, that Advanced Bionics began on November 27, 2025. It covers 2 Sky CI M90 sound processors whose packaging label differs from the product inside [4]. FDA lists the recall as open. It is separate from the 2020 HiRes Ultra implant notice, which concerned hearing degradation.

December 20, 2022: Advanced Bionics Agrees to Pay More than $12 Million

The Department of Justice announced a settlement. Advanced Bionics agreed to pay more than $12 million to resolve allegations about RF emissions testing of its Neptune and Naida processors [5]. The government alleged the company said the processors met a recognized RF emissions standard when they did not. Advanced Bionics denies the government’s claims.

March 10, 2020: FDA Posts HiRes Ultra Field Corrective Action

FDA posted Advanced Bionics’ February 20, 2020 voluntary field corrective action for the initial version of its Ultra and Ultra 3D cochlear implants. The company cited reports of hearing performance degradation [6]. Existing recipients may continue to use their device as normal, the notice said. Recipients with hearing degradation should visit their audiologist or other health care provider.

April 16, 2013: Kentucky Jury Awards $7.25 Million in Sadler Case

A federal jury in the Western District of Kentucky awarded a patient $7.25 million in damages over a recalled HiRes 90K implant that failed from moisture ingress, according to Sonova‘s April 17, 2013 statement [7]. Nearly $6.3 million of the award was punitive damages, MassDevice reported. Sonova said it would review the verdict and consider an appeal [8].

What Is a Cochlear Implant?

According to NIDCD, “a cochlear implant is a small, complex electronic device that can help to provide a sense of sound to a person who is profoundly deaf or severely hard-of-hearing” [9]. The implant has an external portion that sits behind the ear and a second portion that is surgically placed under the skin.

Who May Be Affected?

People with the initial version of an Advanced Bionics HiRes Ultra or Ultra 3D implant may be affected if it failed and needed revision surgery. The company named both in its 2020 field corrective action. The Ontario class covers people implanted in Canada, excluding Quebec. They had a hard failure and revision surgery. A hard failure is a malfunction that testing can measure. An individual legal review decides if a person qualifies.

Reported Injuries or Damages

Plaintiffs in Pedersen allege that fluid seeps into the electrode array. They say it short-circuits the implant. Removing a failed implant takes invasive surgery. A readjustment period follows and does not always restore full hearing. The company’s 2020 notice said hearing degradation could require revision surgery. It also said the only potential for patient harm is the risk of surgery. An Otology and Neurotology study looked at 308 Ultra and Ultra 3D devices at one large program. It found 65 known failures, or 21.1% [10]. The study put the failure trend at about 6% per year. Of the failures, 52 patients (82.5%) chose revision surgery. Most regained or beat their earlier speech scores within 3 months. In the 2013 Sadler case, the plaintiffs alleged an older HiRes 90K implant gave a patient three bouts of shocking. The shocks allegedly caused convulsions and vomiting.

Recall and Regulatory Background

Advanced Bionics’ February 2020 field corrective action, posted by FDA, followed reports of hearing performance degradation with fluid ingress at the electrode. By February 11, 2020, fewer than 0.5% of more than 16,000 recipients had been explanted for this reason. A recall does not prove liability. The cochlear implant recall page has more detail.

Evidence to Preserve

Keep these records if your Advanced Bionics implant failed or needed revision surgery:

• Your device model and serial number, plus the implant card you got after surgery
• The date of your surgery and the surgeon’s report on the implant procedure
• Hearing test records, including your mapping or fitting history and notes on any drop in hearing
• Impedance and electrical field imaging test results from before and after the problem began
• Records of any revision surgery, plus the report on the removed device if there is one
• Any letters or notices from Advanced Bionics or your implant clinic about the device
• Medical bills, insurance statements and records of lost work tied to the problem

Filing Deadlines

Deadlines to file a claim come from state law. They differ by where the person lives and when the implant failed, the injury happened or the problem was found. Some places start the clock at the surgery or the discovery of the defect. Even a claim with strong facts can be lost once the filing window closes. A person who had an implant problem should check with a lawyer promptly about the deadline that applies to their own situation.

Frequently Asked Questions

What Damages Issues Did the Ontario Court Certify in Pedersen?

The Ontario court certified damages issues in Pedersen. Compensatory damages may be set at a base level for injuries common to people with revision surgery. Punitive damages may be assessed class-wide. Negligent manufacturing was dropped before the hearing.

How Many Pedersen Class Members Were Minors at Implantation?

About 50 of the Pedersen class members were minors at implantation. They are part of the national class the Ontario court certified. It covers people implanted across Canada outside Quebec.

What Does the Research Say About HiRes Ultra Implant Failures?

The research on HiRes Ultra implant failures tied 63 of the study’s 65 known failures to the field corrective action. That is 20.5% of devices studied. Average time to failure was 2.2 years.

Does the Ontario Court Say How Many Implants Failed?

The Ontario court recorded evidence that up to half of the defendants’ devices have failed. The figure comes from the court record at certification. It is not a finding on liability.

References

1. https://app.midpage.ai/document/wieder-v-advanced-bionics-llc–305047be-cc44-4a54-827a-59a6b6494678
2. https://www.law360.ca/ca/articles/2504003/court-reduces-costs-by-50-for-medical-ear-implant-class-action-certification
3. https://www.casemine.com/judgement/us/69ce0903493b3e63c19a0b3f
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=217750
5. https://oig.hhs.gov/fraud/enforcement/advanced-bionics-llc-to-pay-over-12-million-for-alleged-false-claims-for-cochlear-implant-processors/
6. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-field-corrective-action-hires-ultra-and-ultra-3d
7. https://www.sonova.com/statement-verdict-regarding-advanced-bionics/
8. https://www.massdevice.com/jury-hits-advanced-bionics-with-7m-judgment-over-recalled-hires-90k-cochlear-implant/
9. https://www.nidcd.nih.gov/health/cochlear-implants
10. https://pmc.ncbi.nlm.nih.gov/articles/PMC9335892/