Neuro Cochlear Implant System M80185Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03663227801859), received between Jun 30, 2022 and Apr 10, 2024 — classified as 10 injuries, 11 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2024Failure to Read Input Signal; Failure to Read Input Signal

  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 19078464 ↗
• 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 19002171 ↗
• InjuryMar 25, 2024Failure to Read Input Signal; Failure to Read Input Signal

  THE OTICON MEDICAL REPRESENTATIVE REPORTED : "ON (B)(6) 2023 : THE PATIENT CALLED TO THE HOSPITAL REFERRING CUTS WHILE USING THE IMPLANT. THE CLINICIAN IN THE HOSPITAL HAD CHANGED THE CABLE AND IT WORKED FOR A WEEK. AFTER THAT, THE PATIENT REFERRED TO NO SOUND AT ALL." AN EXPLANTATION AND REIMPLANTATION WERE PERFORMED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 18969008 ↗
• InjuryNov 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED: "SENSATIONS OF CRACKLING BY THE PATIENT DESPITE NEW SETTINGS MADE." THE COCHLEAR IMPLANT NEURO ZTI EVO, SERIAL NUMBER (B)(6) WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Tinnitus

  MAUDE report 18082516 ↗
• MalfunctionOct 24, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTS A COMMUNICATION/TRANSMISSION PROBLEMS.

  Patient problems: Failure of Implant

  MAUDE report 17994024 ↗
• MalfunctionAug 28, 2023Connection Problem; Connection Problem

  THE PATIENT REPORTED SOUND CUTS.

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

  MAUDE report 17630642 ↗
• MalfunctionJul 17, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE CLINICIAN REPORTED A COMMUNICATION ISSUE WITH THE IMPLANT. AT THIS STAGE, EXPLANTATION OF THE DEVICE IS ENVISAGED. THE SCHEDULED DATE OF SURGERY HAS NOT BEEN COMMUNICATED. IN VIVO ANALYSIS WAS PERFORMED BY THE CLINICIAN, IT WAS NOT POSSIBLE TO COMMUNICATE WITH THE IMPLANT DESPITE VARIOUS COMBINATIONS USE: CHANGE OF MAGNET, ANTENNA AND SOUND PROCESSOR.

  Patient problems: Failure of Implant

  MAUDE report 17331203 ↗
• MalfunctionJul 13, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE CUSTOMER REPORTED : "LOSS OF COMMUNICATION". OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE PATIENT SUDDENLY STOP HEARING. VARIOUS ACCESSORY CHANGES DID NOT PERMIT TO SOLVE THE PROBLEM. DUE TO THE LACK OF COMMUNICATION WITH THE IMPLANT, IMPEDANCE MEASUREMENT AND ELECTRODE INTEGRITY TESTS COULD NOT BE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 17314645 ↗
• MalfunctionJul 13, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE PATIENT COULD HEAR NOTHING WHILE USING SPEECH PROCESSOR ON THE LEFT SIDE SINCE THE PROBLEM OCCURED: A SUDDEN DECREASE OF PERFORMANCE. OTICON MEDICAL REPRESENTATIVE REPORTS ALSO AN IMPACT ON THE IMPLANT WITH HEMATOMA. IN VIVO ANALYSIS PERFORMED BY THE OTICON MEDICAL REPRESENTATIVE ON (B)(6), 2022 REVEALED INFINITE IMPEDANCE ON 18 OUT OF 20 ELECTRODES.

  Patient problems: Failure of Implant; Hematoma

  MAUDE report 17314469 ↗
• InjuryMay 16, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE NEURELEC - OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE IN VIVO TESTING WAS DONE BY THE CLINIC STAFF WITH REMOTE SUPERVISION. COMMUNICATION WITH THE IMPLANT COULD NOT BE ESTABLISHED, SO NO FURTHER TESTS COULD BE PERFORMED. DESPITE A SOUND PROCESSOR CHANGE AND DIFFERENT'S ANTENNA AND MAGNET COMBINATIONS, INCLUDING USE OF SPACER, THE PROBLEM REMAINED.

  Patient problems: Failure of Implant

  MAUDE report 16938510 ↗
• MalfunctionApr 27, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THAT THE PATIENT INDICATES NO HEARING SOUND. DESPITE THE ANTENNA, AND CABLE CHANGES, THE PROBLEM PERSISTS.

  Patient problems: Insufficient Information

  MAUDE report 16824139 ↗
• MalfunctionApr 27, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTS AN INABILITY TO COMMUNICATE WITH THE COCHLEAR IMPLANT DURING THE IMPLANT ACTIVATION SESSION. DESPITE THE USE OF SEVERAL ANTENNAS, SOUND PROCESSORS AND MAGNETS, THE PROBLEM PERSISTS.

  Patient problems: Failure of Implant

  MAUDE report 16822097 ↗
• InjuryJan 20, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  AN IN VIVO ANALYSIS WAS PERFORMED BY THE OTICON MEDICAL REPRESENTATIVE ON DECEMBER 23RD, 2022. THE PATIENT REPORTED A LOSS OF COMMUNICATION DURING THE LAST DAYS, INTERMITTENTLY. ON THE DATE OF THE ANALYSIS, THERE IS NO COMMUNICATION BETWEEN THE SOUND PROCESSOR AND THE IMPLANT. IT WAS NOT POSSIBLE TO CONNECT WITH THE IMPLANT DESPITE THE USE OF DIFFERENT ANTENNAS, CABLES AND MAGNETS, SAME RESULTS ARE OBSERVED WITH ANOTHER SOUND PROCESSOR. 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 16215332 ↗
• MalfunctionJan 20, 2023Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  THE DECISION TO EXPLANT THE PATIENT WAS MADE BY THE MEDICAL TEAM. THE EXPECTED EXPLANT DATE IS NOT KNOWN AT THIS STAGE. IN VIVO ANALYSIS WAS PERFORMED. OTICON MEDICAL REPRESENTATIVE REPORTED THE IMPOSSIBILITY TO CONNECT WITH THE COCHEAR IMPLANT DESPITE SOUND PROCESSOR, ANTENNAS, MAGNETS 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 16215259 ↗
• InjurySep 23, 2022Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  IN VIVO TESTS WERE PERFORMED ON (B)(6) 2022 BY OTICON MEDICAL REPRESENTATIVE. OTICON MEDICAL REPRESENTATIVE REPORTED A SUDDEN LOSS OF HEARING. ELECTRICAL ARTEFACTS MEASUREMENTS AND IMPEDANCE MEASUREMENTS COULD NOT BE PERFORMED DUE TO THE INABILITY TO CONNECT THE NEURO ZTI EVO IMPLANT, SERIAL NUMBER (B)(4) TO THE SOUND PROCESSOR.

  Patient problems: Failure of Implant

  MAUDE report 15474642 ↗
• MalfunctionSep 23, 2022Failure to Read Input Signal; Communication or Transmission Problem; Failure to Read Input Signal; Communication or Transmission Problem

  IN VIVO ANALYSIS WAS PERFORMED ON MAY 18TH, 2022 BY OTICON MEDICAL REPRESENTATIVE. OTICON MEDICAL REPRESENTATIVE REPORTED THE IMPOSSIBILITY TO CONNECT WITH THE NEURO ZTI EVO IMPLANT, SERIAL NUMBER (B)(4) DESPITE CHANGES IN CABLE, ANTENNA, MAGNET AND SOUND PROCESSOR . 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 15474241 ↗
• InjurySep 1, 2022Failure to Read Input Signal; Communication or Transmission Problem; Connection Problem; Failure to Read Input Signal; Communication or Transmission Problem; Connection Problem

  A DECREASE IN PERFORMANCE IS NOTICED WITH THE NEURO ZTI IMPLANT, SERIAL NUMBER (B)(4) BY AN OTICON MEDICAL REPRESENTATIVE FOLLOWING A CALL FROM ONE OF THE DUTCH IMPLANTION CENTERS, ERASMUS ROTTERDAM. OTICON MEDICAL REPRESENTATIVE REPORTED A SUDDEN LOSS OF COMMUNICATION AFTER A BRIEF HUMMING AND BUZZING SOUND BETWEEN THE IMPLANT AND THE SOUND PROCESSOR.

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

  MAUDE report 15334214 ↗
• InjuryJun 30, 2022Electrical /Electronic Property Problem; Connection Problem; Electrical /Electronic Property Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE "IMPLANT WAS NOT WORKING ANYMORE".

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

  MAUDE report 14876168 ↗
• InjuryJun 30, 2022Connection Problem; Connection Problem

  THE OTICON MEDICAL REPRESENTATIVE REPORTED THAT NO CONNECTION TO THE NEURO ZTI EVO IMPLANT COULD BE ESTABLISHED DESPITE DIFFERENT CONFIGURATIONS TESTED : ANTENNA CHANGES, USE OF MAGNETS OF DIFFERENT STRENGTHS AND OTHER PROCESSORS (NEURO 2 AND NEURO ONE). THE OTICON MEDICAL REPRESENTATIVE ALSO REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY MISHAPS OR HITS ON HIS HEAD.

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

  MAUDE report 14875561 ↗
• InjuryJun 30, 2022Communication or Transmission Problem; Connection Problem; Intermittent Communication Failure; Communication or Transmission Problem; Connection Problem; Intermittent Communication Failure

  OTICON MEDICAL REPRESENTATIVE REPORTED A LOSS OF COMMUNICATION WITH THE COCHLEAR IMPLANT NEURO ZTI EVO SERIAL NUMBER (B)(4).

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

  MAUDE report 14875075 ↗
• InjuryJun 30, 2022Failure to Read Input Signal; Communication or Transmission Problem; Connection Problem; Failure to Read Input Signal; Communication or Transmission Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE CONNECTION BETWEEN THE PROCESSOR AND THE RECEIVER PART WAS LOST.

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

  MAUDE report 14874380 ↗