SONATATI100 +MEDIUM 04913Recalls & reported problems

Summary

The FDA's MAUDE database contains 101 adverse event reports that list this exact device (DI 09008737049133), received between Jun 1, 2015 and Sep 8, 2026 — classified as 41 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Output Problem” (63 reports).

4 other recalls cover devices cleared under the same FDA submission (P000025); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 101 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  The recipient was implanted in October 2014. The audiologist attempted to perform Auto ART, however, he reported significant discomfort, particularly in the left ear, which was more sensitive than the right. She verified that he had previously shown neural responses; however, it was no longer able to visualize any responses during (b)(6)2025's session. This may be partly due to the lower current levels used in this session. However, even during the follow-up appointment, when higher current levels were applied, no responses were recorded. The user has been re-implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668807 ↗
• InjuryJul 30, 2026Device Appears to Trigger Rejection

  The user went to an ENT clinic for ear canal cleaning. The doctor by mistake sucked the electrode out of the cochlea. The active electrode now is in the EAC.The user has been explanted.

  Patient problems: Infectious Otitis Media; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084387 ↗
• MalfunctionApr 7, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24797039 ↗
• MalfunctionMar 18, 2026Circuit Failure; Impedance Problem

  THE USER CAME TO THE HOSPITAL WITH A REPORT OF ROAD TRAFFIC ACCIDENT ON (B)(6) 2026. AFTER THE INCIDENT, THERE WAS BLEEDING FROM THE RIGHT EAR WHICH WAS PROMPTLY SHOWN TO AN ENT SURGEON. THERE WAS BLEEDING FROM LOWER AND POSTERIOR TYMPANIC MEMBRANE. POST THIS INCIDENT, THE CHILD HAS NOT BEEN ABLE TO HEAR ANYTHING ON THE RIGHT EAR. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN.

  Patient problems: Head Injury

  MAUDE report 24627006 ↗
• MalfunctionOct 28, 2025Impedance Problem; Impedance Problem

  THE USER SUFFERED FROM A TRAUMA; AFTERWARD, HE ONLY HEARD A BUZZING SOUND AND REFUSED TO USE THE PROCESSOR. REIMPLANTATION MIGHT BE CONSIDERED.

  Patient problems: Head Injury

  MAUDE report 23404282 ↗
• MalfunctionOct 10, 2025Impedance Problem; Impedance Problem

  THE USER HAS A DECLINE IN HIS HEARING PERFORMANCE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23264128 ↗
• MalfunctionOct 2, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23199057 ↗
• MalfunctionSep 18, 2025Impedance Problem; Impedance Problem

  THE USER WAS NOT RESPONDING TO SOUNDS FOR THE LAST 2-3 MONTHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084382 ↗
• MalfunctionAug 11, 2025Impedance Problem; Impedance Problem

  THE FAMILY REPORTED THAT THEY HAVE ALWAYS NOTICED THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE WAS POOR ONLY ON THIS RIGHT SIDE. THE RECIPIENT ALWAYS MENTIONED HIGH VOLUME AND DISCOMFORT. DURING IN SITU TESTING, ANTENNA IN PLACE FOR A FEW MINUTES, THE PATIENT EXHIBITS REDNESS IN THE AREA. FURTHER TECHNICAL CHECKS AND RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22768904 ↗
• MalfunctionMay 21, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT DID NOT SEE THE CLINICIAN FOR THE ANNUAL FITTING FOR THE PAST 4 YEARS. SHE WENT TO SEE HER DOCTOR AND REPORTED THAT SHE WAS NOT HEARING PROPERLY WITH HER DEVICE. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22059779 ↗
• MalfunctionMay 9, 2025Impedance Problem; Impedance Problem

  ALTHOUGH THE FAMILY DID NOT REPORT ANY SPECIFIC TRAUMA, THEY SAID THAT THE CHILD IS VERY ACTIVE AND COULD HAVE BEEN HIT HIS HEAD WITHOUT THE FAMILY SEEING. DURING THE SESSION, THE CHILD NEVER STOPPED AND TENDED TO CLIMB THINGS ALL THE TIME. BOTH SIDE AFFECTED CHANNELS WERE DETECTED ON THE SAME DAY. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992593 ↗
• MalfunctionMay 9, 2025Impedance Problem; Impedance Problem

  ALTHOUGH THE FAMILY DID NOT REPORT ANY SPECIFIC TRAUMA, THEY SAID THAT THE CHILD IS VERY ACTIVE AND COULD HAVE BEEN HIT HIS HEAD WITHOUT THE FAMILY SEEING. DURING THE SESSION, THE CHILD NEVER STOPPED AND TENDED TO CLIMB THINGS ALL THE TIME. BOTH SIDE AFFECTED CHANNELS WERE DETECTED ON THE SAME DAY. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21992588 ↗
• MalfunctionFeb 21, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT REPORTED WORSENING OF HEARING PERFORMANCE WITH THE DEVICE. FURTHER PROCEEDINGS ARE UNKNOWN.

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

  MAUDE report 21430219 ↗
• MalfunctionDec 17, 2024Malposition of Device; Adverse Event Without Identified Device or Use Problem; Migration; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Migration

  THE RECIPIENT HAD CARDIOLOGICAL PROBLEM DURING THE SURGERY AND IT WAS NOT POSSIBLE TO ACHIEVE A FULL INSERTION. THE RECIPIENT REPORTED THAT HE CANNOT HEAR WELL WITH THE RIGHT-SIDE DEVICE. IT WAS REPORTED THAT 5 CHANNELS WERE LEFT EXTRA COCHLEAR AT IMPLANTATION. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 20949311 ↗
• MalfunctionDec 2, 2024Impedance Problem; Impedance Problem

  THE PARENTS REPORTED THAT THE RECIPIENT COULD NOT HEAR SOUNDS WITH THE RIGHT-SIDE DEVICE ON (B)(6) 2024. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20818699 ↗
• InjuryNov 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER EXPERIENCED MENINGITIS 3-4 TIMES AFTER IMPLANTATION ON (B)(6) 2023. ACCORDING TO THE USER'S PARENT, THE MENINGITIS EPISODES INITIALLY OCCURRED IN (B)(6) 2023 AND REOCCURRED TWO OR THREE TIMES IN THE FOLLOWING 4 MONTHS AND AGAIN IN (B)(6) 2024. THE USER WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Meningitis

  MAUDE report 20692994 ↗
• MalfunctionJul 23, 2024Impedance Problem; Impedance Problem

  A MONTH AGO THE RECIPIENT BANGED HIS HEAD WHILE HE WAS PLAYING WITH HIS COUSINS. THE FAMILY DID NOT REALIZE THAT THERE WAS A PROBLEM WITH THE CHILD'S HEARING AT THAT TIME. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19804273 ↗
• MalfunctionJun 17, 2024Impedance Problem; Impedance Problem

  PARENT AND SPEECH THERAPIST REPORTED A DECREASE IN HEARING PERFORMANCE WITH THE DEVICE OF THE CHILD WITH RESPECT TO SPEECH AND LANGUAGE TASKS. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 19545960 ↗
• MalfunctionMay 21, 2024Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS. THE RECIPIENT HAS BEEN RE-IMPLANTED.

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

  MAUDE report 19359012 ↗
• MalfunctionApr 26, 2024Impedance Problem; Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE WAS REPORTEDLY AFFECTED. IN SITU TESTING SHOWED AFFECTED CHANNELS. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 19189702 ↗
• MalfunctionMar 14, 2024Impedance Problem; Impedance Problem

  IN MARCH 2024, THE RECIPIENT STOPPED HEARING WITH THE DEVICE AFTER HAVING BUMPED HER HEAD. RE-IMPLANTATION HAS BEEN SCHEDULED FOR (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 18902758 ↗
• MalfunctionFeb 21, 2024Impedance Problem; Impedance Problem

  THE USER HAS NO SOUND PERCEPTION WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 18745222 ↗
• MalfunctionDec 29, 2023Circuit Failure; Insufficient Device Problem Information; Circuit Failure; Insufficient Device Problem Information

  WHEN THE USER WAS FOLLOWED UP, IT WAS NOT POSSIBLE TO VISUALIZE ESRT RESPONSES UNLIKE IN PREVIOUS EXAMS IN WHICH RESPONSES WERE RECORDED ON ALL CHANNELS. THE NEURAL RESPONSES (ART) ALSO SEEMED TO HAVE AN ATYPICAL MORPHOLOGY, AND DURING TESTS, MAESTRO SIGNALLED SEVERAL TIMES ABOUT THE COMPLIANCE/LOAD ON THE ELECTRODES. THESE OBSERVED CHANGES AND A CHANNEL WITH ABNORMAL IMPEDANCE CAUGHT THE ATTENTION OF THE IMPLANT TEAM. AS PER ADDITIONAL INFORMATION THE RECIPIENT KEEPS ATYPICAL NEURAL RESPONSES AND VARIATIONS BETWEEN THE OUTCOMES. REPORTEDLY, THERE IS NO EVOLUTION IN ORAL LANGUAGE DEVELOPMENT AS WELL AS IN AUDITORY SKILLS AS THE RECIPIENT ONLY DETECTS SOUNDS. ADDITIONAL MEASUREMENTS PERFORMED ON 16-OCT-2023 HAVE BEEN REVIEWED BY CLINICAL SUPPORT AND IT WAS INDICATED THAT THE DEVICE IS NO LONGER WORKING WITHIN SPECIFICATIONS. REIMPLANTATION IS NOW CONSIDERED.

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

  MAUDE report 18417225 ↗
• MalfunctionOct 30, 2023Impedance Problem; Impedance Problem

  THE CHILD WAS BROUGHT BY THE PARENTS FOR REGULAR FOLLOW-UP WITH THE AUDIOLOGIST. PARENTS REPORTED THAT THE CHILD RESPONDED TO MOST OF THE SOUNDS AND COMMON WORDS (ALSO OBSERVED DURING THE SESSION), BUT DID NOT TALK APART FROM VOCALIZING /AA/. NO OTHER TECHNICAL CHECKS HAVE BEEN SCHEDULED. DIAGNOSTIC IMAGE REPORT IS AWAITED.

  Patient problems: Failure of Implant

  MAUDE report 18029696 ↗
• InjuryJul 24, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER WAS ACTIVATED IN (B)(6) 2022. AROUND THAT TIME THERE WAS A SLIGHT DISCHARGE COMING FROM THE SCAR. THE SURGEON PRESCRIBED ANTIBIOTICS. AFTERWARDS, SHE WAS ABLE TO WEAR HER PROCESSOR AND WAS SATISFIED. IN (B)(6) 2023, THE PROBLEM REOCCURRED AND IN THE BEGINNING OF (B)(6), THE CLINICIAN SAW CLEARLY THE BEGINNING OF EXTRUSION OF THE IMPLANT.

  Patient problems: Tissue Breakdown

  MAUDE report 17377022 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000025. One submission often covers many models, so check the product and lot details in each record.

• Z-2356-2024 · Apr 18, 2024 · Open, Classified
  Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
• Z-2138-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used toge
• Z-2137-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard Product
• Z-2136-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCE