MAUDE Adverse Event Report: Sonova AG Phonak CROS L-R; Contralateral hearing unit

Model Number	0501013P5
Medical Device Problem Codes	Overheating of Device (1437); Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sonova received a repair order stating that the device got very hot, almost burned the patient and won't charge.
Additional Manufacturer Narrative
The manufacturer received the complaint and initiated an investigation.(3316) the manufacturer has checked service records of the subject device and established that there were no service cases logged before this incident.(3331, 4112) the device is not avaiable for the analysis, however, traceability data was verified to confirm the li-ion battery model used in the device.Overall, the available information is consistent with an internal short circuit of the built-in rechargeable li-ion battery, related to the generation of particles during thermal cutting of the battery at the supplier.In rare cases, these particles may cause an internal battery short circuit, resulting in a thermal event and immediate 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 cease 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, any resulting injury is expected to be limited and fully heal within a short period of time without causing permanent harm.Therefore, the manufacturer considers that the residual risk is outweighed by the benefit.(36) the risk assessment already considers and addresses risk items concerning overheating of the device.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.(4582) no actual injury or symptoms were reported in the complaint.The concern related solely to the potential for harm to the patient.(4109) no other similar serious or non-serious complaints have been identified globally for this product within the last 12 months.The manufacturer will continue to monitor this issue for trends.

• Brand Name: Phonak CROS L-R
• Common Device Name: Contralateral hearing unit
• 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: 50472832
• Report Number: 3005085999-2026-00021
• Device Sequence Number: 10204593
• Product Code: OSM
• UDI-Device Identifier: 07613389502954
• UDI-Public: (01)07613389502954
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/27/2026

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: 0501013P5
• 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: 07/29/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2026
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown