Overview
Advanced Bionics recalled its HiRes Ultra and Ultra 3D cochlear implants in February 2020 after reports of device failures due to fluid ingress at the electrode, leading to performance issues like hearing degradation. These implants, designed to restore auditory sensation for those with profound hearing loss, were linked to significant complications, with over one-third of devices at one institution requiring surgical removal.
Additionally, the company faced a $13 million settlement in 2022 for allegedly submitting false data to the FDA about radio-frequency (RF) emissions for its Neptune and Naida processors, misleading federal healthcare programs like Medicare and Medicaid. Class action lawsuits in Canada and individual lawsuits in the U.S. are now seeking compensation for affected patients, citing medical costs, pain, and suffering caused by these defects [1][2][3][4].
Affected Cochlear Implant Models
The lawsuits and recalls focus on the following Advanced Bionics cochlear implant models:
- HiRes Ultra: Recalled in 2020 due to fluid ingress causing hearing degradation.
- HiRes Ultra 3D: Similarly recalled, with reported failures requiring revision surgeries.
- Neptune and Naida Processors: Cited in a 2022 False Claims Act settlement for misrepresented RF emissions data, potentially compromising device safety.
Patients can identify affected devices by checking serial numbers (for HiRes models, typically between 1,000,000 and 1,999,999) or consulting their audiologist or surgeon [3][1].
Hazards of Defective Cochlear Implants
The defective cochlear implants pose significant risks, including:
- Hearing performance degradation, reducing or eliminating auditory function.
- Need for revision surgeries, which carry risks of infection, facial nerve damage, or dizziness.
- Potential RF interference from Neptune and Naida processors, affecting nearby devices like phones or alarms.
- Emotional distress and financial burdens from medical interventions and device failure.
These issues are particularly impactful for children, who represent a large demographic of cochlear implant recipients, often receiving implants as young as six months [4][3].
Symptoms of Cochlear Implant Failure
Patients with defective Advanced Bionics cochlear implants may experience:
- Gradual or sudden loss of sound clarity or volume.
- Distorted or intermittent hearing, impacting speech recognition.
- Discomfort or pain at the implant site, potentially indicating fluid ingress.
- Dizziness, vertigo, or seizures linked to device malfunction.
- Interference with electronic devices due to excessive RF emissions.
These symptoms often necessitate medical evaluation and may lead to revision surgery to replace the faulty implant [4][2].
Consumer Actions and Legal Remedies
Patients with affected cochlear implants should immediately contact their audiologist or surgeon to confirm the device model and assess performance issues. Advanced Bionics has pulled unimplanted HiRes Ultra and Ultra 3D devices from the market, but those already implanted may require surgical intervention. Consumers can reach out to law firms like Gluckstein Lawyers (Canada) or those partnered with ClassAction.org (U.S.) to explore eligibility for lawsuits. Documentation, such as medical records and device serial numbers, is critical for claims. The 2022 settlement resolved False Claims Act allegations without admitting liability, but ongoing lawsuits seek compensation for medical expenses, pain, suffering, and punitive damages for negligence [3][4][1].
Potential for a Class Action Lawsuit
The widespread impact of Advanced Bionics’ defective cochlear implants, coupled with allegations of regulatory fraud, provides strong grounds for class action lawsuits, particularly in Canada, where Gluckstein Lawyers and partners have launched a class action for HiRes Ultra and Ultra 3D recipients. In the U.S., individual lawsuits are preferred due to the severity of injuries, with potential claims for medical costs, revision surgery expenses, and emotional distress. The 2020 recall affected thousands, with studies reporting a 34% explant rate at one institution, underscoring the scale of the issue. Allegations that Advanced Bionics knowingly misrepresented RF emissions data further fuel claims of negligence and fraud, potentially warranting punitive damages to deter future misconduct [3][4][2].
Do I Have a Cochlear Implant Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in cochlear implant lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Cochlear Implant Class Action Lawsuit Evaluation: If you or a loved one experienced hearing degradation, required revision surgery, or suffered other complications from an Advanced Bionics cochlear implant, you should contact our law firm immediately. You may be entitled to compensation by filing a cochlear implant class action suit, and our lawyers can help.
References
- https://www.fcacounsel.com/blog/advanced-bionics-settles-false-claims-act-case-for-13-million/
- https://www.justice.gov/archives/opa/pr/advanced-bionics-llc-pay-over-12-million-alleged-false-claims-cochlear-implant-processors
- https://www.gluckstein.com/news-item/gluckstein-lawyers-launches-advanced-bionics-cochlear-implant-class-action-lawsuit
- https://www.classaction.org/cochlear-implant-lawsuits-advanced-bionics