Advanced Bionics Recalls HiResolution Bionic Ear Systems Due to Fluid Entry
Advanced Bionics is recalling 8,159 HiResolution Bionic Ear Systems because body fluid may enter the device, causing hearing performance degradation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 hearing performance degradation due to fluid entry, which is a risk-of-harm product issue where specific injuries or illnesses are not explicitly reported in the provided text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Advanced Bionics, LLC is recalling 8,159 units of the AB HiResolution Bionic Ear System, specifically the HiRes Ultra 3D CI models with HiFocus SlimJ Electrodes. The recall covers model numbers CI 1601 04 (3,827 units) and CI 1601 05 (4,332 units) with lot numbers ranging from 1000000 to 1999999. These devices are intended to restore auditory sensation to patients with profound sensorineural deafness via electrical stimulation of the auditory nerve.
The recall was initiated because body fluid may enter the device, which can lead to hearing performance degradation. The affected units were distributed worldwide, including in the United States, Canada, Brazil, and numerous other countries. The source text does not specify the exact number of affected patients or report any specific injuries or illnesses resulting from this defect.
Consumers and healthcare providers with these specific model and lot numbers should contact Advanced Bionics for instructions on how to address the potential fluid entry issue. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- AB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ 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.
See all 2 products in this recall →Related recalls
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Same hazard · fluid entry
See all →- HighSynthes Sciatic Nerve Retractor Recalled for Potential Microspore Formation
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