Beltone 20968075Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05708296157716), received between May 31, 2022 and May 31, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 31, 2022Material Separation; Material Separation

  ON 05MAY2002 IT WAS REPORTED: SF3 RECEIVER BROKEN IN THE EAR CANAL. THE END USER HAS BEEN ADVISED TO SEEK MEDICAL ATTENTION FOR REMOVAL. AT THE TIME OF WRITING, WE ARE AWAITING A RESPONSE TO THIS. PATIENT DID NOT USE SPORTS LOCK. 10-MAY-2022: INITIAL REPORTABILITY RATIONALE. THE CURRENT INFORMATION INDICATES NEED FOR IMMEDIATE REPORTING. ATTACHED REPORTING DECISION TREE SUPPORT THE REPORTABILITY DECISION. BASED ON THE EVENT DESCRIPTION AND THE RISK REGISTER REFERENCE THE EVENT/ INCIDENT DID LEAD TO, OR MIGHT LED TO A SERIOUS INJURY. THE EVENT DESCRIBED [?]SF3 RECEIVER BROKEN IN THE EAR CANAL. THE END USER HAS BEEN ADVISED TO SEEK MEDICAL ATTENTION FOR REMOVAL. AT THE TIME OF WRITING, WE ARE AWAITING A RESPONSE TO THIS. PATIENT DID NOT USE SPORTS LOCK.' ON 11-MAY-2022: FOLLOW UP RECEIVED. THE INCIDENT HAPPENED BETWEEN 03RD TO 5TH MAY 2022. NO DAMAGE TO THE EAR CANAL HAS BEEN REPORTED. THE CASE OWNER INFORMED THAT THE REST OF THE RECEIVER WAS REMOVED FROM THE EAR CANAL BY A MEDICAL DOCTOR AND THERE WAS NO HARM TO THE EAR CANAL. THE INFORMATION DOES NOT ALTER THE INITIAL REPORTABILITY RATIONALE. RISK REGISTER REFERENCE: RISK REGISTER REFERENCE: (B)(4) GEN BTE & ITE RISK ANALYSIS RISK

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 14548432 ↗