Fortell AI Hearing Aid KITPK-001-SLVRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00860014635809), received between May 14, 2026 and Jun 4, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Detachment of Device or Device Component

  PATIENT REPORTED ON MAY 15TH THAT HE HAD BEEN TO THE ENT AFTER NOTICING DIFFICULTY HEARING AND EXPERIENCING A SENSATION OF WATER IN LEFT EAR. THE ENT REMOVED 3 DOMES FROM HIS LEFT EAR. THE DOMES WERE SUCCESSFULLY REMOVED FROM THE EAR CANAL. AT THE TIME OF THE INITIAL REPORT, IT WAS CONFIRMED THERE WAS NO PAIN OR DISCOMFORT AFTER THE REMOVAL OF THE DOMES. NO MEDICAL TREATMENT WAS PRESCRIBED AFTER THESE EVENTS. MULTIPLE ATTEMPTS WERE MADE TO CONTACT THE PATIENT ON (B)(6) TO OBTAIN ADDITIONAL INFORMATION BUT THE PATIENT DID NOT RESPOND TO THESE ATTEMPTS FOR FOLLOW-UP. DOCUMENTATION FROM THE VISIT NOTE FROM THE PATIENT'S MOST RECENT PRIOR AUDIOLOGY VISIT (B)(6) 2026) CONFIRMS THAT HE WAS INSTRUCTED TO ONLY USE FORTELL-PROVIDED DOMES. HE STATED THE DAY OF THE REPORT THAT HE HAD BEEN BUYING 8MM DOMES ONLINE. AT THE TIME OF THE REPORT, THE PATIENT WAS PROVIDED FORTELL-COMPATIBLE DOMES. THE RISK ASSESSMENT FOR THE DEVICE EVALUATES THE DOME DETACHING FROM THE DEVICE AND GETTING STUCK IN THE EAR CANAL, WHICH IS MITIGATED BY THE SPECIFIED RETENTION FORCE FOR DOMES PROVIDED BY FORTELL (IN COMPLIANCE WITH IEC 60601-2-66). THE INSTRUCTIONS FOR USE STATES TO GET HELP IF A PIECE, SUCH AS THE DOME,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25400008 ↗
• MalfunctionMay 14, 2026Detachment of Device or Device Component

  PATIENT REPORTED ON (B)(6) THAT THERE WERE TWO PREVIOUS INSTANCES IN WHICH THE RUBBER TIP (DOME) FELL DOWN THE EAR CANAL AND HAD TO BE REMOVED IN AN EMERGENCY ROOM. PATIENT REPORTED HE WENT TO URGENT CARE AROUND (B)(6) 2026 AND WENT TO THE ER ON (B)(6) 2026. THE PATIENT REPORTED THIS HAPPENED FOR THE RIGHT-HAND SIDE DEVICE BOTH TIMES. THE USER REPORTED HE WAS USING THE DOMES PROVIDED BY THE AUDIOLOGIST, MEDIUM CLOSED DOMES. THE DOME WAS SUCCESSFULLY REMOVED FROM THE EAR CANAL WITHOUT PAIN BOTH TIMES. NO MEDICAL TREATMENT WAS PRESCRIBED AFTER THESE EVENTS. THE RISK ASSESSMENT FOR THE DEVICE EVALUATES THE DOME DETACHING FROM THE DEVICE AND GETTING STUCK IN THE EAR CANAL, WHICH IS MITIGATED BY SPECIFIED RETENTION FORCE (IN COMPLIANCE WITH IEC 60601-2-66). THE INSTRUCTIONS FOR USE STATES TO GET MEDICAL HELP IF A PIECE, SUCH AS THE DOME, GETS STUCK IN THE PATIENT'S EAR, AND INSTRUCTS TO NOT PUSH THE PART FURTHER IN THE EAR, TO REDUCE THE RISK OF SERIOUS INJURY AS FAR AS POSSIBLE. THEREFORE, IT IS CONCLUDED THE CURRENT RISK ASSESSMENT IS ACCEPTABLE. NO FURTHER FOLLOW-UP IS EXPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25175065 ↗