Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Ingress
Advanced Bionics is recalling HiResolution Bionic Ear Systems because body fluid can enter the device, causing hearing performance degradation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional failure (hearing performance degradation) in a medical device intended for patients with profound deafness, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Advanced Bionics, LLC is recalling the AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode. The recall involves 14,068 units, specifically model numbers CI-1600-04 and CI-1600-05, with lot numbers ranging from 1000000 to 1999999.
The recall is being conducted because body fluid can enter the device, which leads to hearing performance degradation. The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
The affected units were distributed worldwide, including in the United States, Canada, and numerous other countries. The source text does not specify the exact actions consumers or patients should take, nor does it report any specific injuries or illnesses associated with the defect.
The recalled product
- Product
- AB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The device is intended to restore a level of auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
- Manufacturer
- Advanced Bionics, LLC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Advanced Bionics, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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