Urgent Field Action Notification of Advanced Bionics HiRes Ultra / Ultra 3D

HSA Singapore issued an urgent field action for Advanced Bionics cochlear implants due to potential device performance issues.

Source updated: Jun 4, 2026

Primary source: HSA

PV Impact Brief

Urgency: HighConfidence: high

What changed

HSA Singapore published an urgent field action notification for Advanced Bionics HiRes Ultra / Ultra 3D cochlear implants regarding potential device performance issues.

Why it matters

Affected devices may fail or show reduced performance, potentially impacting patient hearing outcomes and requiring active monitoring or replacement.

Action needed

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Relevant for: Regulatory Intelligence LeadSignal Management Lead
Processes impacted: Signal ManagementLabeling
Owner: Regulatory Intelligence Lead
Review cadence: one-time

Regulatory action details

Action type: Urgent Field Action
Publication date: 2026-06-04
Safety issue: Urgent field action notification for cochlear implants regarding potential device performance issues.

Affected products

Advanced Bionics HiRes Ultra / Ultra 3D

PV internal implications

Healthcare providers should notify patients and monitor for any device failure or reduced performance.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 4, 2026

HSA →Updated June 4, 2026

Full briefing

Practical implication

Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

Singapore HSA notified about potential performance issues with Advanced Bionics HiRes Ultra / Ultra 3D cochlear implants. Healthcare providers should inform patients and monitor for device failure or reduced performance.

What changed: HSA Singapore published an urgent field action notification for Advanced Bionics HiRes Ultra / Ultra 3D cochlear implants regarding potential device performance issues.

Why it matters: Affected devices may fail or show reduced performance, potentially impacting patient hearing outcomes and requiring active monitoring or replacement.

Practical implication: Healthcare providers must notify patients of potential device performance issues and monitor for any device failure or reduced performance signs.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals #firecrawl-agent #regulatory-extraction #Other #HSA #Urgent Field Action

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