MAUDE Adverse Event Report: FORTELL RESEARCH INC. FORTELL AI HEARING AID; Hearing Aid, Air-Conduction with Wireless Technology, Prescription

Model Number	FR1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device, including the affected domes, was not returned for further evaluation.This is a combined (initial and final) report.
Event or Problem Description
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.

• Brand Name: FORTELL AI HEARING AID
• Common Device Name: Hearing Aid, Air-Conduction with Wireless Technology, Prescription
• Manufacturer (Section D): FORTELL RESEARCH INC.; 379 w broadway; new york NY 10012
• Manufacturer Contact: 379 w broadway; new york, NY 10012 ; 9174105407
• MDR Report Key: 25175065
• Report Number: 3041897366-2026-00001
• Device Sequence Number: 21474547
• Product Code: OSM
• UDI-Device Identifier: 00860014635809
• UDI-Public: (01)00860014635809
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: FR1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White