MAUDE Adverse Event Report: SONOVA AG UNITRON MOXI S7-R; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	050-6913-P2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Blister (4537)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that blistering behind the ear was observed in a patient.Ent has set the patient on medication, steroid cream.The patient was fitted with the device on (b)(6) 2025 and cshells on (b)(6) 2025.The patient had seen the blistering on skin behind ear on (b)(6) 2025 but he didn't go to md until few days ago.The patient started cream recently.Md felt there may be leakage from aid and requested device replacement.It was said the aids were sent in for repair with new housing and cshell for remake.It was reported the issue is only behind one ear.The other ear was reported fine.The ear was put on rest to let it heal.The patient would be without one aid until the ear heals.Planned was a return to md for clearance followed by fitting with repaired aid.Patient has allergy to nickel but no other things.

• Brand Name: UNITRON MOXI S7-R
• Common Device Name: HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich ,che 8712 ; SZ 8712
• MDR Report Key: 23901292
• Report Number: 3008848788-2025-00023
• Device Sequence Number: 10116735
• Product Code: OSM
• UDI-Device Identifier: 07613389770568
• UDI-Public: (01)07613389770568
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2025
• Report Date (Section F): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 050-6913-P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/05/2025
• Device Age: 5 MO
• Event Location: Other
• Date Report to Manufacturer: 12/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown