MAUDE Adverse Event Report: Sonova AG Phonak Audeo M30-R; Hearing aid, air-conduction, receiver-in-canal

Model Number	050-0439-P5
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885)
Health Effect - Clinical Code	Skin Burning Sensation (4540)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sonova was notified that a hearing aid became hot while being worn by a user, resulting in a burning sensation to the back of the ear.The user removed the device due to the heat.Following the event, the device would not power on or charge and was reported as non-functional.
Additional Manufacturer Narrative
The manufacturer received the complaint and initiated an investigation.(3316) the device history and available service records were reviewed.(3331) production and traceability records were reviewed and confirmed the rechargeable lithium-ion battery model installed in the subject device.The subject device was not available for direct examination.Therefore, the investigation was based on the complaint information, follow-up information provided by the user, hearing care professional, device history, and available production and traceability records.(4112) based on the available information, the manufacturer considers an internal short circuit within the built-in rechargeable lithium-ion battery to be a possible cause of, or contributing factor to, the reported overheating event.The suspected internal battery short circuit may be associated with certain process parameters applied by the battery supplier during battery-cell production.Although these parameters were within the applicable specifications, parameters at the lower end of the specified range may have resulted in insufficient removal of particles generated during the manufacturing process.In rare circumstances, residual particles could contribute to an internal short circuit within the battery.An internal battery short circuit may result in a thermal event, rapid battery depletion, heating of the external device housing, and subsequent loss of device function.If the device housing becomes hot while the hearing aid is being worn, the user may experience heat, stinging, discomfort, temporary skin discoloration, or skin irritation behind the ear.In a less favorable exposure scenario, prolonged contact with the heated device surface could result in a localized thermal injury requiring medical attention.However, the device has limited thermal mass, the housing has low thermal conductivity, and the hearing aid can be removed after the heat is noticed.These factors may limit the duration and extent of exposure.Any resulting localized injury would therefore be expected to be limited and to resolve without permanent impairment.The manufacturer considers that the clinical benefits of the device continue to outweigh the associated residual risk.(36)the applicable risk-management documentation and product labeling were reviewed.The risk-management documentation addresses overheating of rechargeable hearing aids, including overheating potentially caused by an internal battery short circuit.The instructions for use advise users to contact their hearing care professional or physician if they experience pain in or behind the ear, inflammation, skin irritation, or another abnormal reaction.The instructions also advise users to protect the hearing aids from external heat and not to leave them near a window or inside a vehicle.These labeling provisions address the actions to be taken in response to abnormal reactions and precautions relating to external heat exposure.The information obtained during the investigation supports that the subject hearing aid became hot while being worn behind the ear.(4216) according to the information received, the hearing aid became excessively hot while being worn, resulting in a burning sensation behind the ear and along the side of the neck.The user was in a vehicle at the time of the event and removed the device as quickly as possible after noticing the heat.The user's daughter reportedly observed redness in the area where the device had contacted the skin.The device was set aside and allowed to cool for approximately one hour.When the user subsequently attempted to use the device, it was non-functional and would not charge.The available follow-up information did not confirm any clinical injury apart from heat sensation.No additional clinical signs, symptoms, or medical conditions associated with the event were reported.The user did not seek medical attention, and no medical treatment or medical intervention was provided.Therefore, no health impact was confirmed.(2199) because the subject device was not available for direct examination, the suspected internal battery short circuit could not be confirmed as the definitive root cause of the event.Historical complaint data for the subject model were reviewed.(4109) based on this review, no positive trend associated with overheating was identified for the subject model in the united states or globally.The manufacturer will continue to monitor complaint data for similar events and potential adverse trends.This is a combined initial and final report.

• Brand Name: Phonak Audeo M30-R
• Common Device Name: Hearing aid, air-conduction, receiver-in-canal
• Manufacturer (Section D): Sonova AG; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 50840843
• Report Number: 3005085999-2026-00028
• Device Sequence Number: 16018191
• Product Code: OSM
• UDI-Device Identifier: 07613275639900
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 050-0439-P5
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 12/20/2020
• 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