Advanced Bionics recalls HiResolution Bionic Ear Systems (model CI 1601 04/05) due to hearing performance degradation from body fluids entering the device. Affected units sold with lot numbers 1000000-1999999.
hearing performance degradation due to body-fluid entering the device.
Advanced Bionics is recalling its HiResolution Bionic Ear Systems (HiRes Ultra 3D CI and HiFocus SlimJ Electrode models) because body fluids can enter the device and cause hearing performance issues. This affects patients with profound sensorineural deafness who use the device for auditory sensation restoration.
Body fluids can enter the device during normal use, leading to hearing performance degradation. This occurs because the device is designed to stimulate the auditory nerve through electrical signals, and bodily fluids may interfere with this process.
Patients with profound sensorineural deafness who use the Advanced Bionics Bionic Ear System are most at risk. The recall applies to specific model numbers and lot ranges sold between 2010 and 2020.
Check for model numbers CI 1601 04 (HiRes Ultra 3D with HF Mid-Scala Electrode) or CI 1601 05 (HiRes Ultra 3D with HF SlimJ Electrode). Affected units have lot numbers from 1000000 to 1999999.
Identify your device model number to confirm if it matches CI 1601 04 or CI 1601 05.
Reach out to Advanced Bionics directly for guidance on next steps.
The recall is due to hearing performance degradation caused by body fluids entering the device during normal use.
Models CI 1601 04 (HiRes Ultra 3D with HF Mid-Scala Electrode) and CI 1601 05 (HiRes Ultra 3D with HF SlimJ Electrode).
Check for lot numbers between 1000000 and 1999999 on your device packaging or documentation.
We’ve drafted a message you can send Advanced Bionics to request your refund or repair — edit it as you like.
Subject: Recall Z-2032-2020 — Advanced Bionics Advanced Bionics Hello, I own a Advanced Bionics that is covered by recall Z-2032-2020 from Advanced Bionics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
