Neuro Cochlear Implant System M80184Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 03663227801842), received between Jul 20, 2022 and Apr 10, 2024 — classified as 6 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (13 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Communication or Transmission Problem; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED A DEVICE FAILURE ON THE COCHLEAR IMPLANT. AT THIS STAGE, AN EXPLANTATION IS SUGGESTED. THE SCHEDULED EXPLANTATION DATE WAS NOT COMMUNICATED.

  Patient problems: Failure of Implant

  MAUDE report 19077390 ↗
• MalfunctionMar 29, 2024Failure to Read Input Signal; Failure to Read Input Signal

  THE OTICON MEDICAL REPRESENTATIVE REPORTS A COMMUNICATION/TRANSMISSION PROBLEMS.AT THIS STAGE, AN EXPLANTATION IS SUGGESTED. THE SCHEDULED EXPLANTATION DATE WAS NOT COMMUNICATED.

  Patient problems: Failure of Implant

  MAUDE report 19003109 ↗
• MalfunctionJan 2, 2024Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE PATIENT SUDDENLY STOPPED HEARING. IN VIVO ANALYSIS WAS PERFORMED ON (B)(6) 2023. COMMUNICATION ISSUE WAS HIGHLIGHTED WITH THE COCHLEAR IMPLANT. THE PLANNED EXPLANTATION DATE HAS NOT BEEN COMMUNICATED. NEURELEC - OTICON MEDICAL WILL ASSUME DESTRUCTIVE ANALYSIS CAN BEGIN 10 DAYS FOLLOWING ISSUANCE OF THIS INITIAL INCIDENT REPORT, UNLESS THE NATIONAL COMPETENT AUTHORITY CONTACTS NEURELEC - OTICON MEDICAL WITHIN THIS TIME FRAME OPPOSING A DESTRUCTIVE ANALYSIS OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18425710 ↗
• MalfunctionJan 2, 2024Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE PATIENT SUDDENLY STOPPED HEARING. IN VIVO ANALYSIS WAS PERFORMED ON (B)(6) 2023. COMMUNICATION ISSUE WAS HIGHLIGHTED WITH THE COCHLEAR IMPLANT. THE PLANNED EXPLANTATION DATE HAS NOT BEEN COMMUNICATED. NEURELEC - OTICON MEDICAL WILL ASSUME DESTRUCTIVE ANALYSIS CAN BEGIN 10 DAYS FOLLOWING ISSUANCE OF THIS INITIAL INCIDENT REPORT, UNLESS THE NATIONAL COMPETENT AUTHORITY CONTACTS NEURELEC - OTICON MEDICAL WITHIN THIS TIME FRAME OPPOSING A DESTRUCTIVE ANALYSIS OF THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18425525 ↗
• InjuryOct 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEPTION OF EXPLANTATION FORM WITH REASON : RECALL.. AN EXPLANTATION AND REIMPLANTATION TOOK PLACE ON B)(6) 2023.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 18001303 ↗
• MalfunctionSep 7, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED A DEVICE FAILURE ON THE COCHLEAR IMPLANT. AT THIS STAGE, AN EXPLANTATION IS SUGGESTED. THE SCHEDULED EXPLANTATION DATE WAS NOT COMMUNICATED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17698816 ↗
• MalfunctionAug 21, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THE COMMUNICATION WITH THE IMPLANT COULD NOT BE ESTABLISHED, SO NO FURTHER TESTS COULD BE PERFORMED. DESPITE A SOUND PROCESSOR CHANGE AND DIFFERENTS ANTENNA AND MAGNET COMBINATIONS, INCLUDING USE OF SPACER, THE PROBLEM REMAINED. THE PATIENT REPORTED (WITH TRANSLATION): "ELECTRIC CURRENT" AND "PAIN". AT THIS STAGE, AN EXPLANTATION OF THE DEVICE IS ENVISAGED.

  Patient problems: Ear Pain; Failure of Implant

  MAUDE report 17583630 ↗
• InjuryAug 11, 2023Failure to Read Input Signal; Communication or Transmission Problem; Intermittent Communication Failure; Failure to Read Input Signal; Communication or Transmission Problem; Intermittent Communication Failure

  IN VIVO ANALYSIS WAS PERFORMED ON (B)(6), 2022 BY THE OTICON MEDICAL REPRESENTATIVE. NO IMPEDANCE MEASUREMENTS COULD BE MADE DUE TO THE LACK OF COMMUNICATION WITH THE INTERNAL PART. SIMILARLY, ELECTRODE INTEGRITY TESTING AND PEAE TESTING COULD NOT BE PERFORMED DUE TO THE LACK OF COMMUNICATION WITH THE COCHLEAR IMPLANT. ON (B)(6) 2022 : THE CONNECTION BETWEEN THE SOUND PROCESSOR AND THE IMPLANT HAS BEEN RESTORED. THE OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE IMPEDANCE MEASUREMENTS WERE CONFORM TO SPECIFICATIONS. THE PROBLEM SEEMED TO HAVE BEEN SOLVED. THE IMPLANT WAS RECEIVED ON (B)(6), 2023. THE EXPLANTATION DATE WAS NOT COMMUNICATED AND WAS ESTIMATED ON (B)(6) 2023. THE REASONS FOR THE EXPLANTATION WERE NOT PROVIDED BY THE CUSTOMER.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17507891 ↗
• MalfunctionJul 17, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED A LOSS OF COMMUNICATION WITH THE IMPLANT. AT THIS STAGE, EXPLANTATION OF THE DEVICE IS ENVISAGED. THE SCHEDULED DATE OF SURGERY HAS NOT BEEN COMMUNICATED.

  Patient problems: Failure of Implant

  MAUDE report 17331154 ↗
• MalfunctionMay 2, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THE INABILITY TO COMMUNICATE WITH THE COCHLEAR IMPLANT. DESPITE THE ANTENNAS, MAGNETS, CABLES AND PROCESSORS CHANGES, THE PROBLEM PERSISTS. AT THIS STAGE THE EXPLANTATION OF THE DEVICE HAS BEEN PLANNED, THE DATE OF THE EXPLANTATION HAS NOT BEEN COMMUNICATED.

  Patient problems: Failure of Implant

  MAUDE report 16851820 ↗
• MalfunctionMay 2, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THE INABILITY TO COMMUNICATE WITH THE COCHLEAR IMPLANT. DESPITE THE ANTENNAS, MAGNETS, CABLES AND PROCESSORS CHANGES, THE PROBLEM PERSISTS. AT THIS STAGE THE EXPLANTATION OF THE DEVICE HAS BEEN PLANNED, THE DATE OF THE EXPLANTATION HAS NOT BEEN COMMUNICATED.

  Patient problems: Failure of Implant

  MAUDE report 16851645 ↗
• MalfunctionMay 2, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THE INABILITY TO COMMUNICATE WITH THE COCHLEAR IMPLANT. DESPITE THE ANTENNAS, MAGNETS, CABLES AND PROCESSORS CHANGES, THE PROBLEM PERSISTS. AT THIS STAGE THE EXPLANTATION OF THE DEVICE HAS BEEN PLANNED, THE DATE OF THE EXPLANTATION HAS NOT BEEN COMMUNICATED.

  Patient problems: Failure of Implant

  MAUDE report 16851595 ↗
• MalfunctionJan 20, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DECISION TO EXPLANT THE PATIENT WAS MADE BY THE MEDICAL TEAM. THE EXPECTED EXPLANT DATE IS NOT KNOWN AT THIS STAGE. SIMILARLY, THE REASONS FOR THE EXPLANTATION HAVE NOT BEEN COMMUNICATED.

  Patient problems: Insufficient Information

  MAUDE report 16215239 ↗
• MalfunctionJan 13, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE PATIENT REPORTED THAT THE IMPLANT HAD SUDDENLY STOPPED WORKING. AN IN VIVO ANALYSIS WAS PERFORMED BY THE OTICON MEDICAL REPRESENTATIVE ON (B)(6) 2022. OTICON MEDICAL REPRESENTATIVE DID NOT PERFORM THE IMPEDANCE MEASUREMENT AND ELECTRICAL ARTEFACTS ANALYSIS DUE TO THE IMPOSSIBILITY TO CONNECT WITH THE IMPLANT. DESPITE CHANGES IN MAGNETS, ANTENNAS AND SOUND PROCESSOR, THE RESULTS REMAINED SIMILAR. THE DECISION TO EXPLANT THE PATIENT WAS MADE BY THE MEDICAL TEAM. THE EXPECTED EXPLANT DATE IS NOT KNOWN AT THIS STAGE.

  Patient problems: Failure of Implant

  MAUDE report 16155964 ↗
• InjuryNov 16, 2022Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  IN VIVO ANALYSIS WAS PERFORMED ON AUGUST 11TH, 2022 BY THE OTICON MEDICAL REPRESENTATIVE. THE OTICON MEDICAL REPRESENTATIVE REPORTED A SUDDEN STOPPING OF IMPLANT IN (B)(6) 2022. NO IMPACT REPORTED BY PARENTS AND RELATIVES. THE PATIENT COMPLAINED OF PAIN AND LACK OF SOUND. THE PATIENT IS PRONE TO EPILEPTIC SEIZURES ON A REGULAR BASIS AND MAY HAVE FALLEN DURING ONE OF HIS SEIZURES. AN IMPEDANCE MEASUREMENT WAS OBTAINED BUT WAS NOT REPRODUCIBLE. COMMUNICATION DIFFICULTIES WITH THE IMPLANT OCCURED DURING THE TEST. THE PATIENT EXPERIENCED PAIN DURING THE IMPEDANCES MEASUREMENT ATTEMPTS AND WAS UNWILLING TO CONTINUE WITH THE ENTIRE EXAMINATION. THE TEST WAS PERFORMED WITH A REFERENCE SOUND PROCESSOR.

  Patient problems: Ear Pain; Failure of Implant

  MAUDE report 15803382 ↗
• MalfunctionNov 4, 2022Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  IN VIVO ANALYSIS WAS PERFORMED ON OCTOBER 4TH, 2022 BY THE OTICON MEDICAL REPRESENTATIVE. THE OTICON MEDICAL REPRESENTATIVE REPORTED A SUDDEN LOSS OF HEARING. IN ADDITION, THE OTICON MEDICAL REPRESENTATIVE REPORTED THE IMPOSSIBILITY TO CONNECT WITH THE COCHLEAR IMPLANT DESPITE SOUND PROCESSOR CHANGES. ELECTRICAL ARTEFACTS MEASUREMENTS AND IMPEDANCE MEASUREMENTS COULD NOT BE PERFORMED DUE TO THE INABILITY OF CONNECTION WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15727045 ↗
• InjuryAug 1, 2022Connection Problem; Connection Problem

  OTICON MEDICAL REPRESENTATIVE REPORTED A CONNECTIVITY ISSUE WITH THE (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138132 ↗
• InjuryAug 1, 2022Failure to Read Input Signal; Communication or Transmission Problem; Connection Problem; Failure to Read Input Signal; Communication or Transmission Problem; Connection Problem

  OTICON MEDICAL REPRESENTATIVE REPORTED A CONNECTIVITY ISSUE WITH THE IMPLANT (B)(4).

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15138118 ↗
• InjuryJul 20, 2022Connection Problem; Connection Problem

  THE CUSTOMER REPORTED : "NO CONNECTION BETWEEN EXTERNAL AND INTERNAL PART." THE COCHLEAR IMPLANT NEURO ZTI CLA, SERIAL NUMBER (B)(4) WAS EXPLANTED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15066152 ↗