MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÉO P90-R; AIR-CONDUCTION HEARING AID, IN-CANAL

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sonova was notified about an incident concerning a patient with dementia who swallowed the entire hearing aid.The patient has been taken to the er.At the time of this notification there was no medical issues or sickness, and the er was following aid through intestines.

• Brand Name: PHONAK AUDÉO P90-R
• Common Device Name: AIR-CONDUCTION HEARING AID, IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich, che 8712 ; SZ 8712
• MDR Report Key: 25154151
• Report Number: 3008848788-2026-00005
• Device Sequence Number: 9397275
• Product Code: OSM
• UDI-Device Identifier: 07613389350951
• UDI-Public: (01)07613389350951
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/24/2026
• Report Date (Section F): 04/24/2026

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/03/2026
• Device Age: 5 YR
• Event Location: Home
• Date Report to Manufacturer: 04/24/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2026
• 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