MAUDE Adverse Event Report: Sonova AG Phonak Audéo L90-R; Hearing aid, 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	Malfunction
Event or Problem Description
The manufacturer received a complaint stating that the hearing aid got very hot behind the ear and then switched off.
Additional Manufacturer Narrative
The complaint was received and investigated.(b32/3316) the manufacturer checked service records of the subject device and established that there was no prior device service before this incident.(b14/3331) traceability data has been verified to confirm the li-ion battery model the device has been produced with.The device was serviced and is not available for analysis, therefore the definitive root cause cannot be confirmed.(b15/4112) however, provided information allowed the manufacturer to suspect that an internal short circuit of a built-in rechargeable li-ion battery could have caused or contributed to the event.The suspected internal li-ion battery short might have been correlated to certain process parameters set by the battery supplier during battery cell production.Although within specifications, the lower range parameters set might have led to an insufficient removal of particles generated during manufacturing process, that in turn could have led to a relatively higher rate of internal short circuits in the battery.An internal short circuit of the battery can lead to a thermal event and instant battery depletion.This may cause the device to heat up, with the external housing becoming hot to the touch.Due to the complete discharge of the battery the device will stop functioning.In such instances, the user can perceive a sensation of stinging or heat on their ear, potentially accompanied by redness or physical signs of irritation.In a worst-case scenario, local heating of the hearing aid surface may cause second-degree burns to the user, which may be painful, can blister or scar and in some instances may require medical attention.However, due to the small thermal mass of the device, its low heat conductivity, and the fact that the hearing aid can be removed, if necessary, any resulting injury is expected to be limited and fully heal within a short period of time without causing permanent harm.No actual injury resulting from this event was recorded in the complaint.The incident is being reported due to the potential for injury associated with the sudden thermal event and hot housing surface.The risk assessment files already consider and address risk items concerning overheating of the device.The manufacturer considers that the residual risk is outweighed by the benefit.The risk assessment files already consider and address risk items concerning overheating of the device.(b31/36) the ifu informs patients that if they feel pain in or behind the ear, if it is inflamed or experience skin irritation, they should consult with their hearing care professional or physician.(b11/4109) sonova regularly monitors the safety and performance of our devices on the market.There have been no positive trends identified locally or globally for this issue.

• Brand Name: Phonak Audéo L90-R
• Common Device Name: Hearing aid, receiver-in-canal
• Manufacturer (Section D): Sonova AG; laubisruetistrasse 28; staefa, 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; staefa, 8712 ; SZ 8712
• MDR Report Key: 50664238
• Report Number: 3005085999-2026-00025
• Device Sequence Number: 21372083
• Product Code: OSM
• UDI-Device Identifier: 07613389477832
• UDI-Public: (01)07613389477832
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: 0500889P5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown