MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÉO P50-R; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	050-0793-P3
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer has initiated a follow up to establish details of the incident and whether the patient has suffered any harm.Manufacturer has requested the device for analysis.This is the initial report.Follow up report will be submitted upon receipt of further information.
Event or Problem Description
It has been brought to the manufacturers attention that the hearing aids (phonak audéo p50-r sn: (b)(6)) are swollen.There has been no patient inury or other health symptoms reported.
Additional Manufacturer Narrative
The hcp confirmed that patient experience no harm due to swollen hearing aids but was not able to provide more information about the circumstances.There was no service history recorded for these devices prior to this event.Devices were returned to the manufacturer for analysis.Devices looked swollen but still worked perfectly fine and were charging.We opened the device and measured dimensions of electronic parts and housing parts and identified that electronic is fine and not swollen.Housing parts were not swollen but contracted at the centerline (between top and bottom housing part), which is the reason that it looked swollen.We installed this electronics into a new housing and all worked and looked fine.We strongly assume that this device got exposed to temperatures above 60°c (e.G.Microwave, oven) which caused deformation of the housing.The risk file already considers a risk of user drying hearing aids in a microwave or similar device and implements information for safety.The accompanying user guide specifies operating (+5 to +40°c), transport and storage (-20°c to +60°c) conditions and provides information on product safety such as to protect hearing aids from heat and to never use microwave or other heating devices to dry hearing aids.Based on the device analysis we concluded that the devices have not malfunctioned and we ruled out design issues.The swelling most likely occurred due to the use errors caused by a user's failure to pay attention to e.G.Instructions in the user guide.

• Brand Name: PHONAK AUDÉO P50-R
• Common Device Name: HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 22381001
• Report Number: 3005085999-2025-00013
• Device Sequence Number: 21191384
• Product Code: OSM
• UDI-Device Identifier: 07613389509755
• UDI-Public: 07613389509755
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 050-0793-P3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: S/N: (B)(6), THE SAME REF. & UDI.
• Patient Sex: Unknown