MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO L90-R; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	0500889P5
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer initiated the investigation including a request for the device to be sent to sonova for analysis and triggered follow up interviews.The preliminary findings are as follows.Risk assessment: the risk of device overheating already exists in the risk file.Service and maintenance record: no service history recorded for device prior to this event.Labelling review: the ifu contains information about correct use and care of hearing instrument as well as applicable warnings.The ifu is considered adequate.Supplementary reports will be submitted upon receipt of new information.
Event or Problem Description
Sonova received a complaint involving phonak l90-r used by a 6-year old child.While at school using the hearing aid under regularly, he complained that the device was becoming hot and his teacher removed it from his ear.The device then stopped functioning entirely.Fortunately, no injury occurred, but the incident was concerning due to the overheating occurring directly in a child's ear.
Additional Manufacturer Narrative
Testing of actual/suspected device (10): device was received.The device contains built-in lithium-ion battery.The analysis of available data concluded an internal battery short circuit.Sonova is in contact with the battery supplier.Trend analysis (4110): sonova is monitoring & trending complaints at a regular time intervals.In addition, sonova analysed sales and complaint data between may 2022 and november 2025.The trend analysis took into account this and devices with similar design.There was no trend recorded.Risk assessment: the estimated probability of harm to occur is considered low.Communication/ interviews (4111): follow up information was not received.This is the final report.

• Brand Name: PHONAK AUDEO L90-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: 23849793
• Report Number: 3005085999-2025-00046
• Device Sequence Number: 21321870
• Product Code: OSM
• UDI-Device Identifier: 07613389477832
• UDI-Public: (01)07613389477832
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 0500889P5
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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: (B)(4).
• Patient Age: 6 YR
• Patient Sex: Unknown