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	05/15/2026
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 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, gets stuck in the patient's ear, and instructs not to push the part further in the ear, to reduce the risk of serious injury as far as possible.Additionally, the instructions for use states that if the dome is missing from the receiver after removing the hearing aid, it may still be in your ear canal.If this occurs, contact fortell for assistance.Additionally, the instructions for use states to contact fortell if you need any replacement domes.The risk analysis assesses the risk of the user using incompatible (third-party) domes as a potential cause of use risks related to the adverse event as this represents reasonably foreseeable misuse.Risk controls were in place prior to the event as documented by the ifu and patient visit records and the user failed to follow manufacturer instructions.Thus, it is concluded the current risk assessment is acceptable.No further information is expected to be available.

• 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: 25400008
• Report Number: 3041897366-2026-00002
• Device Sequence Number: 13445934
• 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): 06/04/2026

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: 05/15/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2025
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 70 KG