SONATATI100 +STANDARD 04911Recalls & reported problems
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Med-El Sonata cochlear implant has 685 adverse event reports, with no deaths and 261 injuries. Common problems include output and electrical failures; reports describe users losing hearing benefit, several being re-implanted, and some mention infection or head injury. No recalls name this device. Reports dropped, with 33 in the last year compared with 64 in the year before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 693
- Deaths reported
- 0
- Injuries reported
- 264
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 693 adverse event reports that list this exact device (DI 09008737049119), received between Feb 13, 2015 and Sep 25, 2026 — classified as 264 injuries, 429 malfunctions.
The most frequently reported specific device problem is “Output Problem” (406 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Output Problem406
- Impedance Problem251
- Migration36
- Circuit Failure33
- Adverse Event Without Identified Device or Use Problem23
- Device Appears to Trigger Rejection23
- Insufficient Device Problem Information15
- Device Operates Differently Than Expected12
Patient problems
- Failure of Implant565
- No Clinical Signs, Symptoms or Conditions80
- Head Injury64
- Unspecified Infection23
- Tissue Breakdown11
- Insufficient Information9
- No Information5
- Skin Tears5
Recent adverse event reports
The 25 most recent of 693 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Impedance Problem
InjurySep 15, 2026Migration
According to the information received, the user underwent a reinsertion surgery on (b)(6) 2017.
Patient problems: Insufficient Information
MAUDE report 50770617 ↗MalfunctionSep 9, 2026Impedance Problem
The user no longer has any hearing sensation.Re-implantation is considered.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50688093 ↗MalfunctionSep 8, 2026Impedance Problem
Patient problems: Head Injury
MAUDE report 50670072 ↗MalfunctionAug 20, 2026Impedance Problem
The user has reduced hearing performance after a head trauma, he was hit by a stone. A small wound developed near the receiver coil area.Re-implantation is considered.
Patient problems: Head Injury
MAUDE report 50339160 ↗MalfunctionAug 10, 2026Impedance Problem
The hearing performance with the device is affected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192774 ↗InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem
The user had a purulent inner ear infection and dizziness for more than a month, and also reported processor malfunction.An explantation took place and the side was not reimplanted.
Patient problems: Ear infection
MAUDE report 50142899 ↗InjuryJul 28, 2026Impedance Problem; Migration
The explanted device was received for investigation.The user was re-implanted.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50050726 ↗InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem
EXPLANTATION IN 2021 DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25794926 ↗MalfunctionJun 25, 2026Impedance Problem
The user returned for follow-up care after a long time. Reportedly, the user experienced an electric shock from an electric stove in the past, which she links to the device issue. However, the situation apparently stabilized.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25617562 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
THE USER WAS EXPLANTED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 25483154 ↗MalfunctionJun 1, 2026Impedance Problem
ON (B)(6) 2026, AUDIOLOGIST FOUND HIGH IMPEDANCES DURING TELEMETRY. USER DID NOT REPORT ANY EFFECT ON HEARING BENEFIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25345772 ↗MalfunctionMay 18, 2026Circuit Failure
THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
Patient problems: Head Injury
MAUDE report 25197778 ↗MalfunctionMay 5, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25076970 ↗MalfunctionApr 10, 2026Migration
USER RECENTLY VISITED HOSPITAL FOR TROUBLESHOOTING EXTERNAL DEVICE AND IN SITU TESTING REVEALED HIGH CHANNELS. X-RAY WAS DONE SAME DAY AND FOUND 6-7 ELECTRODE CHANNELS EXTRA COCHLEAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844000 ↗MalfunctionApr 9, 2026Impedance Problem
THE USER EXPERIENCED DECREASING HEARING. THE USER WAS RE-IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24827736 ↗MalfunctionApr 7, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24797028 ↗MalfunctionApr 1, 2026Impedance Problem
THE DEVICE WAS EXPLANTED.
Patient problems: Head Injury; Insufficient Information
MAUDE report 24751334 ↗MalfunctionMar 18, 2026Circuit Failure; Impedance Problem
ON 06-MAR-2026 THE USER REPORTED INTERMITTENT HEARING. THE USER WAS ABLE TO HEAR PROPERLY USING THE LOANER PROCESSOR, AND THEREFORE THE CLINIC ADVISED THE USER TO CONTINUE OBSERVATION WITH THE LOANER PROCESSOR FOR 3_4 DAYS. THE USER REPORTED FOR FOLLOW-UP ON 14-MAR-2026, AGAIN COMPLAINING OF INTERMITTENT HEARING SINCE THAT MORNING. THE CLINIC ATTEMPTED TO REPEAT THE MEASUREMENTS, BUT FAILED TO ACHIEVE THE COMMUNICATION WITH THE IMPLANT. RE-IMPLANTATION IS BEING CONSIDERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630022 ↗MalfunctionMar 12, 2026Impedance Problem
THE USER HAS POOR HEARING AND POOR DISCRIMINATION WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578877 ↗MalfunctionMar 2, 2026Impedance Problem
IN (B)(6) 2025, THE USER REPORTED THAT SHE IS NOT ABLE TO HEAR ANYTHING WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482647 ↗MalfunctionMar 2, 2026Circuit Failure; Impedance Problem
THE USERS HEARING PERFORMANCE HAS DECLINED; 3 DAYS AGO THE DEVICE STARTED GOING ON AND OFF, AND AFTER A DAY THE USER STOPPED HEARING AT ALL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480633 ↗InjuryFeb 25, 2026Device Appears to Trigger Rejection
THE PARENTS BROUGHT THE CHILD TO THE HOSPITAL DUE TO RECURRENT INFECTIONS AND LACK OF RESPONSE TO SOUNDS FOR 1 YEAR. DURING OTOSCOPIC EXAMINATION, THE ELECTRODE LEAD WAS VISIBLE THROUGH THE EAR CANAL.
Patient problems: Tissue Breakdown; Unspecified Infection
MAUDE report 24441489 ↗MalfunctionFeb 23, 2026Impedance Problem
HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IT WAS FIRST NOTICED IN (B)(6) 2025. THE USER WAS RE-IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24411123 ↗MalfunctionFeb 12, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24320477 ↗
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, ClassifiedMi1250 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 · TerminatedMED 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 · TerminatedMED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard
- Z-2136-2019 · Oct 16, 2018 · TerminatedMED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi100
Other Implant, Cochlear devices
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Advanced Bionics AG · Implant, Cochlear2,918 reports
- Cochlear® Nucleus® CI512 cochlear ImplantCochlear Limited · IMPLANT, COCHLEAR2,771 reports
- Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCochlear Limited · Implant, cochlear2,115 reports
- Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCochlear Limited · Implant, cochlear2,057 reports
- Nucleus Z60353Cochlear Limited · IMPLANT, COCHLEAR2 deaths1,815 reports
- Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCochlear Limited · IMPLANT, COCHLEAR1,475 reports
- Cochlear® Nucleus® CI612 cochlear ImplantCochlear Limited · Implant, cochlear1,150 reports
- Nucleus Z190574Cochlear Limited · IMPLANT, COCHLEAR981 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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