MAUDE Adverse Event Report: Sonova AG Sennheiser Sonite R; Hearing aid, air-conduction, receiver-in-canal

Model Number	050-1121-P656
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Sonova was notified that a hearing aid became hot while being worn on the user's ear and subsequently stopped functioning.No visible marks or discoloring were observed on the user's skin following the event.
Additional Manufacturer Narrative
The manufacturer received the complaint and initiated an investigation.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, device history, and available production and traceability records.(3316) the device history and available service records were reviewed.No previous service events involving overheating or a similar problem were identified for the subject device before the reported incident.(3331) production and traceability records were reviewed and confirmed the rechargeable lithium-ion battery model installed in the subject device.(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 on the user's ear and subsequently became non-functional.(4216) according to the follow-up information, the user was sitting on a couch and watching television when the event occurred.After the event, the device was unresponsive both in and out of the charger.No visible marks or skin discoloration were reported.The available follow-up information did not identify any burn or another clinical injury.No additional clinical signs, symptoms, or medical conditions associated with the event were reported.(4582) the available information did not indicate that the user sought medical attention or received medical treatment or intervention.Therefore, no health impact was confirmed.(2199) as no direct device examination results were available at the time of this assessment, 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) no positive trend associated with overheating was identified for the subject model during the the evaluated 12-month period.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: Sennheiser Sonite 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: 50855276
• Report Number: 3005085999-2026-00029
• Device Sequence Number: 15940954
• Product Code: OSM
• UDI-Device Identifier: 07613389804010
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/20/2026

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: 050-1121-P656
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 05/01/2025
• 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: Male