Esteem® Sound Processor 2001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812282020214), received between Feb 21, 2018 and May 13, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P090018); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2025Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  ENVOY MEDICAL CORP. (EMC) WAS NOTIFIED ON 25-APR-2025 THAT THE PATIENT HAD UNDERGONE A REVISION ON (B)(6) 2025 TO ADDRESS LIMITED BENEFIT FROM THE DEVICE AND INTERMITTENCY FOLLOWING A ROUTINE BATTERY CHANGE ON (B)(6) 2025. DURING THE REVISION, THE SURGEON NOTED THAT THE DRIVER LEAD MAY HAVE BEEN PARTIALLY INSERTED IN THE HEADER PORT. LEAD RETRACTION NOT CONFIRMED, BUT CONSERVATIVELY REPORTED OUT OF CAUTION. SURGEON REPLACED THE SOUND PROCESSOR, AND PATIENT CONFIRMED HEARING SHORTLY AFTER SURGERY. PATIENT/CLINICAL HISTORY WITH EMC: ON (B)(6) 2011: IMPLANT, ON (B)(6) 2011: ACTIVATION, ON (B)(6) 2012: FITTING, ON (B)(6) 2012: ENHANCEMENT, ON (B)(6) 2012: FITTING, ON (B)(6) 2012: ANALYSIS, ON (B)(6) 2012: FITTING, ON (B)(6) 2013: FITTING, ON (B)(6) 2013: FITTING, ON (B)(6) 2015: FITTING, ON (B)(6) 2016: BATTERY CHANGE, ON (B)(6) 2016: FITTING AND REMOTE SUPPORT, ON (B)(6) 2018: FITTING AND REMOTE SUPPORT, ON (B)(6) 2021: BATTERY CHANGE, ON (B)(6) 2023: FITTING, ON (B)(6) 2025: BATTERY CHANGE, ON (B)(6) 2025: POST-BATTERY CHANGE/PRE-OP TESTING, ON (B)(6) 2025: REVISION.

  Patient problems: Partial Hearing Loss

  MAUDE report 22014196 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOUND PROCESSOR EXPLANT DUE TO DEVELOPMENT OF SEROMA. PATIENT HISTORY: (B)(6) 2011 - PATIENT INITIALLY IMPLANTED, (B)(6) 2011 - ACTIVATION, (B)(6) 2012 - FITTING, (B)(6) 2016 - BATTERY CHANGE, (B)(6) 2016 - FITTING AND SUMMARY REPORT - NO INDICATIONS OF SEROMA AT THIS VISIT. ON (B)(6) 2018 - PHYSICIAN NOTIFIED ENVOY THAT PATIENT HAS FLUCTUANT MASS, POSSIBLE ABCESS, ON TOP OF SOUND PROCESSOR. PATIENT PRESCRIBED ANTIBIOTICS. ON (B)(6) 2018 - PHYSICIAN REPORTED THAT FLUCTUANT MASS IS SEROMA WITHOUT ANY INDICATIONS OF INFECTION. PATIENT HAS BEEN SCHEDULED FOR DRAINAGE OF SEROMA AND EXPLANT OF SOUND PROCESSOR FOR (B)(6) 2018.

  Patient problems: Discomfort; Pain

  MAUDE report 7286241 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P090018. One submission often covers many models, so check the product and lot details in each record.

• Z-2590-2018 · Jun 28, 2018 · Terminated
  Final Pack, Esteem II, Sound Processor Model 2001, containing 2 Sterile Wipes 002866-001 (which expired in April 2018). An Implantable Middle Ear Hearing Device.
• Z-0750-2013 · Jan 9, 2013 · Terminated
  Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX, part of the Esteem Totally Implantable Hearing System. The ISA and Commander are software packages that run on