HiRes 90K™ Advantage CI HiFocus™ 1j Electrode CI-1500-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 280 adverse event reports that list this exact device (DI 07630016815805), received between Jun 29, 2018 and Sep 24, 2026 — classified as 208 injuries, 72 malfunctions.

The most frequently reported specific device problem is “Expulsion” (46 reports).

17 other recalls cover devices cleared under the same FDA submission (P960058); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 280 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  The recipient reportedly experienced a displaced magnet following an MRI. On (b)(6) 2026, the recipient's magnet was repositioned.

  Patient problems: Headache; Pain

  MAUDE report 50889480 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  The recipient reportedly experienced chronic purulent infections and partial weakness of the facial nerve. The recipient's device was explanted. During the explant surgery, the middle ear was found to be filled with inflammatory granulation tissue, and no symptoms were detected. Examination revealed otosclerosis. The Mendelian bone was removed, and the inflammatory granulation tissue of the middle ear was cleaned. The procedure was performed following tympanoplasty.

  Patient problems: Extraskeletal ossification; Undesired Nerve Stimulation; Wound Infection

  MAUDE report 50437013 ↗
• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING NO SOUND WHEN PROCESSOR IS ON AND FACIAL NERVE STIMULATION, DESPITE DEVICE TESTING WITHIN NORMAL LIMITS. EXTERNAL EQUIPMENT WAS CONFIRMED TO BE WORKING WELL. THE RECIPIENT HAS REPORTEDLY BECAME A NON USER OF THE DEVICE. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 24896160 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED A SKIN FLAP INFECTION. THE RECIPIENT REPORTEDLY HAD MULTIPLE FLUID EXTRACTIONS AND ANTI-INFLAMMATORY TREATMENTS (TYPE UNKNOWN), HOWEVER, THE ISSUE DID NOT RESOLVE. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Medical device site infection; Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 24498236 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT PRESENTED AT THE ER WITH A SUSPECTED BRAIN ABSCESS. THE RECIPIENT UNDERWENT A PETROSECTOMY AND FOUND A CHOLESTEATOMA. THE CHOLESTEATOMA WAS COMPLETELY REMOVED. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE RECIPIENT'S DEVICE WILL REPORTEDLY NOT RETURN TO ADVANCED BIONICS FOR ANALYSIS.

  Patient problems: Cholesteatoma

  MAUDE report 24242500 ↗
• InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED DUE TO A SKIN FLAP ISSUE. 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; Fluid Discharge; Necrosis; Skin Infection; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 24124088 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem; Migration

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS EXPLANTED DUE TO A FISTULA. IT IS NOTED THAT THE DEVICE WAS VISIBLE. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. THE RECIPIENT'S DEVICE WAS ACTIVATED AND PERFORMANCE IS GOOD. THE DEVICE WILL NOT RETURN FOR ANALYSIS.

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 24082637 ↗
• MalfunctionDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THE RECIPIENT'S DEVICE WAS EXPLANTED. PROGRAMMING ADJUSTMENTS HAD BEEN MADE; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. 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 23819172 ↗
• InjuryDec 1, 2025Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED A RUPTURED TYMPANIC MEMBRANE DURING AN EARWAX REMOVAL VISIT. THE RECIPIENT PRESENTED WITH DEVICE EXTRUSION. REVISION SURGERY IS SCHEDULED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23686723 ↗
• MalfunctionOct 22, 2025Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING SIGNIFICANT PAIN WHEN USING THE DEVICE, FOLLOWING AN ELECTROSTATIC DISCHARGE EVENT FROM PLAYING ON A SLIDE. DEVICE TESTING COULD NOT BE COMPLETED DUE TO PAIN. THE RECIPIENT IS REPORTEDLY NOT USING THE DEVICE. REVISION SURGERY IS UNDER CONSIDERATION.

  Patient problems: Electric Shock; Pain

  MAUDE report 23360340 ↗
• InjuryOct 21, 2025Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION CAUSING DEVICE EXTRUSION. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS PRESCRIBED PREDNISOLONE FOR TEN DAYS AND AMOXICILLIN CLAVULANATE FOR FOURTEEN DAYS. THE RECIPIENT WAS NOT REIMPLANTED. THE RECIPIENT IS REPORTEDLY RECOVERING WELL.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 23353936 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED SWELLING AT THE IMPLANT SITE. THE PATIENT WAS REPORTEDLY EXPERIENCING HEADPIECE RETENTION ISSUES. THE RECIPIENT REPORTEDLY HAS THICK SKIN. A CT SCAN CONFIRMED ELECTRODE MIGRATION AND THE DEVICE IN AN IRREGULAR POSITION. REVISION SURGERY IS SCHEDULED.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 23296038 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION. ANTIHISTAMINE AND ANTI-INFECTION DRUGS (TYPE UNKNOWN) WERE USED; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT WAS HOSPITALIZED ON (B)(6) 2025. THE RECIPIENT¿S DEVICE WAS EXPLANTED ON (B)(6) 2025. THE DEVICE IS REPORTED TO HAVE BEEN DISCARDED AND WILL NOT RETURN FOR ANALYSIS. THE RECIPIENT WAS NOT REIMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 22939200 ↗
• MalfunctionAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT¿S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. 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 22879634 ↗
• InjuryAug 7, 2025Migration or Expulsion of Device; Expulsion; Migration; Migration or Expulsion of Device; Expulsion; Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED ELECTRODE MIGRATION. IT IS NOTED THAT THE DEVICE WAS ALLEGEDLY NOT WORKING PRIOR TO EXPLANT (REASON UNKNOWN). 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 22742651 ↗
• InjuryJul 17, 2025Expulsion; Expulsion

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AND DEVICE EXTRUSION. MEDICAL TREATMENT (TYPE UNKNOWN) WAS ADMINISTERED; HOWEVER, THE ISSUE DID NOT RESOLVE. THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WILL NOT BE REIMPLANTED. THE RECIPIENT WAS REPORTEDLY PRESCRIBED ANTIBIOTICS FOLLOWING EXPLANT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 22532312 ↗
• InjuryJul 11, 2025Expulsion; Expulsion

  THE RECIPIENT WAS HAVING WHAT WAS BELIEVED TO BE A CERUMEN PLUG REMOVED FROM THE EXTERNAL AUDITORY CANAL. DURING THE IN-OFFICE PROCEDURE, THE DOCTOR INADVERTENTLY PULLED THE ELECTRODE ARRAY OUT OF THE RECIPIENT'S COCHLEA. 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

  MAUDE report 22485173 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED AN INFECTION AND WAS PRESCRIBED ANTIBIOTICS (TYPE UNKNOWN). THE RECIPIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2025. THE RECIPIENT WAS NOT REIMPLANTED. THE INFECTION HAS RESOLVED FOLLOWING DEVICE EXPLANT.

  Patient problems: Unspecified Infection

  MAUDE report 22214045 ↗
• MalfunctionMay 27, 2025Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED FACIAL NERVE STIMULATION (FNS). THE RECIPIENT'S DEVICE WAS EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

  Patient problems: Failure of Implant; Undesired Nerve Stimulation

  MAUDE report 22088713 ↗
• InjuryMay 13, 2025Expulsion; Adverse Event Without Identified Device or Use Problem; Expulsion; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED EXTRUSION DURING A WAX PLUG REMOVAL PROCEDURE. THE RECIPIENT REPORTEDLY HAS A PERFORATED TYMPANIC MEMBRANE. 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

  MAUDE report 22014678 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT IS REPORTEDLY EXPERIENCING AN INFECTION. THE RECIPIENT WAS DIAGNOSED WITH A RETROAURICULAR ABSCESS THAT REQUIRES DEBRIDEMENT SURGERY. THE RECIPIENT WAS REPORTEDLY PRESCRIBED MEDICATION (TYPE UNKNOWN). A DEBRIDEMENT SURGERY IS UNDER CONSIDERATION.

  Patient problems: Unspecified Infection

  MAUDE report 21913252 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPANY WAS INFORMED THAT THE RECIPIENT'S DEVICE WAS REPORTEDLY EXPLANTED. THE RECIPIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21884588 ↗
• InjuryMar 27, 2025Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem; Electrical /Electronic Property Problem; Electrostatic Discharge; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED OVERLY LOUD SOUND. 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

  MAUDE report 21712687 ↗
• InjuryMar 19, 2025Expulsion; Migration; Expulsion; Migration

  THE RECIPIENT REPORTEDLY EXPERIENCED ELECTRODE EXTRUSION. 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

  MAUDE report 21641852 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REPORTEDLY EXPERIENCED SWELLING. THE RECIPIENT REPORTEDLY HAS A HISTORY OF SWELLING. THE RECIPIENT WAS REPORTEDLY PRESCRIBED A 10 DAY COURSE AUGMENTIN. THE RECIPIENT REPORTEDLY CEASED DEVICE USE. THE RECIPIENT REPORTEDLY DEVELOPED A HEMATOMA. THE RECIPIENT WAS PRESCRIBED AN ADDITIONAL COURSE OF ANTIBIOTICS (TYPES UNKNOWN). THE RECIPIENT REPORTEDLY DISCONTINUED DEVICE USE.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 21632049 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P960058. One submission often covers many models, so check the product and lot details in each record.

• Z-2283-2026 · Apr 30, 2026 · Open, Classified
  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 HiReso
• Z-1950-2026 · Mar 23, 2026 · Open, Classified
  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; C
• Z-1813-2025 · Mar 5, 2025 · Open, Classified
  HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607
• Z-2033-2020 · Feb 17, 2020 · Terminated
  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 sensorine
• Z-2032-2020 · Feb 17, 2020 · 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 prof
• Z-1441-2020 · Apr 4, 2019 · 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
• Z-1259-2020 · Mar 18, 2019 · Terminated
  HiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
• Z-1083-2019 · Feb 6, 2019 · 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.
• Z-1085-2019 · Feb 6, 2019 · Terminated
  Nada CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.
• Z-1084-2019 · Feb 6, 2019 · Terminated
  Nada CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.
• Z-2039-2009 · Jun 10, 2009 · Terminated
  Advanced Bionics HiRes 90K Cochlear Implant, Model: CI-1400-01 and CI-1400-02H, Implant Magnet Case. Cochlear implant intended to restore a level of auditory sensation to patients
• Z-0959-2009 · Jul 24, 2008 · Terminated
  S-Series Short Range Headpiece Model Number MMT-5300-00 (beige) and MMT-5300-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used i
• Z-0957-2009 · Jul 24, 2008 · Terminated
  Platinum Series Headpiece Model Number AB-7300. The headpiece is used in conjunction with speech processors manufactured by Advanced Bionics. The Harmony HiResolution Bionic Ear
• Z-0956-2009 · Jul 24, 2008 · Terminated
  HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with spee
• Z-0958-2009 · Jul 24, 2008 · Terminated
  S-Series Long Range Headpiece Model Number AB-5301-00 (beige) and AB-5301-10 (brown) ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The headpiece is used in

…and 2 more.