HiRes 90K Advantage CI HiFocus MS ElectrodeRecalls & reported problems across all models
Advanced Bionics AG · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 442
- Deaths reported
- 0
- Injuries reported
- 337
- Recalls
- 1
We found 2 models of HiRes 90K Advantage CI HiFocus MS Electrode by Advanced Bionics AG in the FDA's device registry (GUDID). Together they are named in 442 adverse event reports in the FDA's MAUDE database, received between Jun 29, 2018 and Sep 23, 2026 — classified as 337 injuries, 105 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (47 reports).
1 FDA recall record name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
HiRes 90K Advantage CI HiFocus MS Electrode recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 18, 2019Class IIITerminated
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.
Z-1259-2020 · Root cause: Other · Recall details · FDA record ↗
Most reported HiRes 90K Advantage CI HiFocus MS Electrode problems
Device problems
- Adverse Event Without Identified Device or Use Problem220
- Appropriate Device Problem Term/Code Not Available47
- Material Protrusion/Extrusion47
- Expulsion39
- Migration or Expulsion of Device38
- Migration33
- Insufficient Device Problem Information29
- Therapeutic or Diagnostic Output Failure28
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available131
- Pain80
- Unspecified Infection69
- Failure of Implant46
- Insufficient Information41
- No Known Impact Or Consequence To Patient37
- Head Injury27
- Discomfort22
HiRes 90K Advantage CI HiFocus MS Electrode models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04Implant, Cochlear315 reports
- HiRes 90K™ Advantage CI HiFocus™ MS Electrode CI-1500-04Implant, Cochlear1 recall127 reports
Recent HiRes 90K Advantage CI HiFocus MS Electrode adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Infectious Otitis Media
MAUDE report 50876185 ↗MalfunctionSep 8, 2026Noise, Audible; Patient Device Interaction Problem
Patient problems: Dizziness
MAUDE report 50680256 ↗InjuryMay 11, 2026Device Dislodged or Dislocated
THE RECIPIENT REPORTEDLY EXPERIENCED A DISPLACED MAGNET. THE RECIPIENT UNDERWENT SURGERY WHERE THE MAGNET WAS SUCCESSFULLY PUSHED BACK INTO PLACE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25145108 ↗MalfunctionApr 20, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING AN EQUILIBRIUM PROBLEM THAT RESTARTED AFTER USING NEW EXTERNAL EQUIPMENT. THE RECIPIENT WAS ADVISED TO STOP USING THE DEVICE.
Patient problems: Dizziness
MAUDE report 24926099 ↗InjuryApr 13, 2026Device Dislodged or Dislocated
THE RECIPIENT REPORTEDLY EXPERIENCED MAGNET DISPLACEMENT FOLLOWING AN MRI, DUE TO THE BANDAGE PROTOCOL NOT BEING FOLLOWED. THE MAGNET WAS SUCCESSFULLY REPOSITIONED THROUGH EXTERNAL MANIPULATION. THE RECIPIENT EXPERIENCED SOME PAIN, WHICH HAS SINCE RESOLVED, AND THE DEVICE IS NOW FUNCTIONING PROPERLY.
Patient problems: Pain
MAUDE report 24866824 ↗InjuryApr 13, 2026Device Dislodged or Dislocated
THE RECIPIENT REPORTEDLY EXPERIENCED MAGNET DISPLACEMENT FOLLOWING AN MRI, DUE TO THE BANDAGE PROTOCOL NOT BEING FOLLOWED. THE MAGNET WAS SUCCESSFULLY REPOSITIONED THROUGH EXTERNAL MANIPULATION. THE RECIPIENT EXPERIENCED SOME PAIN, WHICH HAS SINCE RESOLVED, AND THE DEVICE IS NOW FUNCTIONING PROPERLY.
Patient problems: Pain
MAUDE report 24866561 ↗InjuryFeb 24, 2026Migration or Expulsion of Device; Expulsion; Adverse Event Without Identified Device or Use Problem
THE RECIPIENT REPORTEDLY EXPERIENCED DEVICE EXTRUSION. IN (B)(6) 2025, THE RECIPIENT PRESENTED WITH SWELLING, CRUSTING AND TENDERNESS: HOWEVER, THE RECIPIENT DID NOT FOLLOW UP. AS A RESULT, THE DEVICE EXTRUDED THROUGH THE SKIN. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS NOT REIMPLANTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Swelling/ Edema
MAUDE report 24437554 ↗InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT REPORTEDLY EXPERIENCED A CHOLESTEATOMA INFECTION AND REQUIRED SURGERY TO REMOVE THE INFECTED TISSUE. THE INFECTION REPORTEDLY REACHED THE IMPLANT, AND THE RECIPIENT'S DEVICE WAS EXPLANTED DUE TO INFECTION FROM CHOLESTEATOMA. THE RECIPIENT WAS IMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Cholesteatoma
MAUDE report 24437088 ↗MalfunctionFeb 20, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE COMPANY WAS INFORMED THE RECIPIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24408140 ↗InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND SWELLING AT THE MAGNET SITE. THE RECIPIENT PRESENTED WITH LIQUID BUILD UP OVER THE MAGNET SITE AS WELL AS TENDERNESS. THE RECIPIENT WAS ADMITTED TO THE HOSPITAL AND WILL BE UNDERGOING TESTING TO DETERMINE CAUSE. IT IS NOTED THAT THE RECIPIENT HAS A SHUNT ON THIS SAME SAID; HOWEVER, IT IS NOT RELATED TO THE DEVICE.
Patient problems: Fluid Discharge; Hematoma; Pain; Swelling/ Edema
MAUDE report 24221382 ↗InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem
THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION. THE RECIPIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Unspecified Infection
MAUDE report 24209285 ↗MalfunctionJan 22, 2026Loose or Intermittent Connection; Intermittent Communication Failure
THE RECIPIENT IS REPORTEDLY EXPERIENCING LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 24156568 ↗MalfunctionJan 19, 2026Mechanical Problem; Electrical Shorting
THE RECIPIENT REPORTEDLY EXPERIENCED DECREASED PERFORMANCE. PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE ISSUE DID NOT RESOLVE. DURING THE PROGRAMMING SESSION IT WAS NOTED THAT THE DEVICE HAD SHORTED ELECTRODES. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 24112064 ↗InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RECIPIENT IS REPORTEDLY EXPERIENCING PAIN AND SWELLING FOLLOWING AN MRI. THE BANDAGE PROTOCOL WAS REPORTEDLY NOT FOLLOWED. THE RECIPIENT WAS REPORTEDLY PRESCRIBED PAIN MEDICATION (TYPE: UNKNOWN). ADVANCED BIONICS IS STILL IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION. WHEN ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Patient problems: Pain; Swelling/ Edema
MAUDE report 23917576 ↗InjuryDec 15, 2025Expulsion; Expulsion
THE RECIPIENT REPORTEDLY EXPERIENCED SKIN BREAKDOWN AND INFECTION DUE TO DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL REPORTEDLY BE REIMPLANTED AT A LATER TIME. THE RECIPIENT'S INFECTION HAS RESOLVED.
Patient problems: Medical device site infection; Necrosis; Skin Infection
MAUDE report 23802454 ↗
Other Advanced Bionics AG products
All Advanced Bionics AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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