Data / Medical devices / United States / Advanced Bionics LLC
Advanced Bionics LLC: FDA-registered device maker in Valencia, CA, United States, 1 PMA approval
Advanced Bionics LLC is registered with the FDA (registration 3009762645) in Valencia, CA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated June 26, 1997. 21 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009762645
- FEI number
- 1000220815
- Address
- 28515 Westinghouse Pl, Valencia, CA, United States, 91355
- Owner or operator
- Advanced Bionics LLC (10023794)
- Roles
- Manufacturer
- First device listed
- December 14, 2007
- Registered through
- 2027
- Brand names listed
- CLARION CII BIONIC EAR, HIRESOLUTION BIONIC EAR SYSTEM, Naida CI Q30, Naida CI Q70, Naida CI Q90, Naida CI M30 Sound Processor, Naida CI M90 Sound Processor, Sky CI M90 Sound Processor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Implant, Cochlear | MCM | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| June 26, 1997 | P960058 | CLARION MULTI-STRATEGY COCHLEAR IMPLANT | MCM | 149 | September 18, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | 98916 | Class II | Ongoing | Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog Number: CI-1601-04 Software Version: N/A Product Description: The HiResolution Bionic Ear System is a cochlear i | Due to incorrect shelf-life expiration date. | accessdata.fda.gov |
| March 23, 2026 | 98678 | Class II | Ongoing | Brand Name: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number: CI-5501-110; CI-5501-120; CI-5501-130; CI-5501-140; CI-5501-150; CI-5501-190; CI-5501-240; CI-5501-250; CI-5501-260; CI | The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery. | accessdata.fda.gov |
| November 27, 2025 | 98161 | Class II | Ongoing | Brand Name: HiResolution Bionic Ear System Product Name: Sky CI M90 Sound Processor Model/Catalog Number: CI-5295-150 | Behind-the-ear sound processer packaging label is different then included product. | accessdata.fda.gov |
| March 5, 2025 | 96668 | Class II | Ongoing | HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607 | Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified. | accessdata.fda.gov |
| September 26, 2020 | 86536 | Class III | Terminated | AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Nada CI Q90 Sound Processor (CI-5280), Nada CI Q70 Sound Processor (CI-5245) and Nada CI Q30 Sound Processor | Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated. | accessdata.fda.gov |
| February 17, 2020 | 85141 | Class II | Terminated | 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 electric | hearing performance degradation due to body-fluid entering the device. | accessdata.fda.gov |
| April 4, 2019 | 84800 | Class III | Terminated | SoundWave Professional Suite Software 3.2, Ref CI-6055-014, SPN 058-023-32085, UDI: (01)07630016853227, Logical SoundWave Professional Suite 3.2, CE 0123 - Product Usage: Soundwave 3.2 is used by healthcare professionals | The manufacturer received complaints that customers were attempting to install the fitting software using the supplied USB drive, an error message was received, and installation failed. The failed installation has not impact to the current version of the software, and users are able to continue programming devices with the current software version. | accessdata.fda.gov |
| March 18, 2019 | 84617 | Class III | Terminated | HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant. | Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. | accessdata.fda.gov |
| February 6, 2019 | 82241 | Class II | Terminated | Nada CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150. | The sound processors were loaded with the incorrect firmware. | accessdata.fda.gov |
| November 23, 2010 | 57349 | Not yet classified | Terminated | Advanced Bionics HiRes 90K Cochlear Implant device (unimplanted units), Model Numbers: CI-1400-01 Intended use: The Harmony HiResolution Bionic Ear system is a cochlear implant system designed to provide useful hearing t | The recall action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device. | accessdata.fda.gov |
| September 22, 2008 | 49525 | Not yet classified | Terminated | Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Power Supply (1) Adhesive Kit ADVANCED BIONICS C | Since April 2004, 27 of 8,769 (0.31%) patients have reported receiving second degree burns in the area of charging and 3 of 8,769 (0.03%) patients have reported receiving third degree burns in the area of charging while using Charger 1.0. Some of these events were the direct result of the patient disregarding the instructions for use, such as sleeping with t | accessdata.fda.gov |
| April 22, 2008 | 49059 | Not yet classified | Terminated | OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, includ | The recall was initiated because there is a possibility that the OMG Connector-A is incorrectly packaged with an OMG Connector-M Instruction manual. | accessdata.fda.gov |
| October 5, 2007 | 45853 | Not yet classified | Terminated | Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342 | Incorrect Data -- Corruption of internal memory component results in an inability for the physician to reprogram the IPG with firmware version prior to Revision 3.02. When this occurs, the IPG will report an error code of "10h0" or "00h0" through the Remote Control. Under this condition, the IPG will cease to log in some data that could be used for informati | accessdata.fda.gov |
| September 14, 2007 | 63353 | Class II | Terminated | HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consist | Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies. | accessdata.fda.gov |
| August 3, 2007 | 39383 | Not yet classified | Terminated | Precision Implantable Pulse Generator (IPG), Model Number SC-110 | Mislabeled: Product labeled with the incorrect shelf-life information. | accessdata.fda.gov |
| January 30, 2007 | 37462 | Not yet classified | Terminated | The Precision Implantable Pulse Generator, Model Number SC-1110 | The Precision Implantable Pulse Generator with firmware Revision 3.01 incorrectly reports an error condition for a valid output from its self internal check. | accessdata.fda.gov |
| September 21, 2006 | 36624 | Not yet classified | Terminated | Advanced Bionics Precision Linear Leads, part of the Precision Spinal Cord Stimulation System. Model Numbers: SC-2138-30, SC-2138-50, SC-2138-50T and SC-2138-70. | A small number of unimplanted Precision Linear Leads may have been assembled with incorrect electrode material. At high stimulation levels, the metal may corrode and dissolved metals may enter the patient. | accessdata.fda.gov |
| March 8, 2006 | 34873 | Not yet classified | Terminated | The unimplanted HiRes90K Implantable Cochlear Stimulators (ICS) manufactured with feedthrus from a specific supplier are being removed from the market. Model number CI-1400-01 | Certain HiRes 90K cochlear implants could fail as a result of elevated moisture levels. The unimplanted HiRes 90K implants listed are being removed from the market. Patients are to be followed for signs of device failure: intermittent function, complete loss of sound, sudden discomfort, pain, noise, or popping. | accessdata.fda.gov |
| November 11, 2004 | 30494 | Not yet classified | Terminated | Charger Assembly, Model # SC-5300, of the PRECISION Spinal Cord Stimulation System | A burn injury was sustained by a patient that did not follow the directions for use and also slept while charging the unit. | accessdata.fda.gov |
| September 27, 2004 | 30209 | Not yet classified | Terminated | Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A | All unimplanted CLARION and HiResolution cochlear implants due to the potential presence of moisture in the internal circuitry, which can cause the device to stop functioning. | accessdata.fda.gov |
| July 27, 2004 | 29687 | Not yet classified | Terminated | Auria PowerPak, Model CI-7400-xxx where xxx denotes color/cable length options. | Battery pack may overheat and cause patient burns. | accessdata.fda.gov |
Compare with other makers
Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.