MAUDE Adverse Event Report: SONOVA AG UNITRON MOXI S7-R; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	050-6913-P2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Blister (4537)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has undertaken several attempts to contact the hcp to gather more information on the incident both by phone and via email.Unsuccessful.No additional information received from the hcp.Although the repair order has been created, the device was not received, therefore the analysis was not possible.It is not confirmed if there was any leakage from the device.The initial information mentions a coexisting condition of the patient which is a known allergy to nickel.Manufacturer has reviewed the device's technical file.It is stated the charging contacts and housing pins of the device are made from a surgical grade titanium alloy (meeting astm f136 requirements).Pins plating is free of nickel, cobalt and lead.After mechanical cycling a nickel and cobalt spot tests confirmed no unexpected release of these metal ions.The devices underwent biological safety evaluation prior to market authorization with the following relevant information: these parts (pins, charging contacts) are in long term contact to the skin with a very small contact area.As required by iso 10993-1:2018 physical and chemical information on the material was obtained according to the material characterization protocol: the material quality with respect to the chemical composition and purity is in compliance with astm f136 (standard specification for wrought titanium-6aluminum-4vanadium eli (extra low interstitial) alloy for surgical implant applications (uns r56401)).A cytotoxicity assay was performed to in order to exclude the presence of any toxic contaminants from the manufacturing process.The result obtained: non-cytotoxic." it is generally known that titanium is considered to be "nickel free," and titanium alloy is commonly used as an alternative to stainless steel alloys for patients who may have nickel sensitivity, it is possible that trace amounts of impurities including nickel could be contained within these materials.However, it is not expected that they would leach in significant amounts and are generally considered safe for individuals with nickel allergies.The reaction could be also related to a mechanical issue (friction, pressure on the skin) and cleaning agents, if any were used.Taking under consideration that the patient has a preexisting allergy to nickel, although unlikely, it can not be completely excluded that the allergy was triggered by the titanium pins.It is also possible that the allergy manifested itself due to other factors not related to the device itself e.G.A residue of a cleaning agent.Despite the follow up attempts, the manufacturer was not able to obtain more information that could help clarify the circumstances of this event.Blisters are known side effects of the hearing aids, this is addressed in the clinical evaluation of the device and disclosed in the user guide.The user guide of the device also contains appropriate caution information instructing the patient to seek physician's advice is itching, redness, blisters, swelling or inflammation occurs in or around ears.Skin reactions, allergic reactions and other risks related to the biocompatibility hazards of the device has already been addressed in the risk management documentation of the device.The residual risk is considered acceptable.The manufacturer checked for similar complaints in the last three years and there have been no trends identified.The manufacturer will keep observing for trends.This is the final report.
Event or Problem Description
It has been brought to manufacturer's attention that blistering behind the ear was observed in a patient.Ent has set the patient on medication, steroid cream.The patient was fitted with the device on (b)(6) 2025 and cshells on (b)(6) 2025.The patient had seen the blistering on skin behind ear on (b)(6) 2025 but he didn't go to md until few days ago.The patient started cream recently.Md felt there may be leakage from aid and requested device replacement.It was said the aids were sent in for repair with new housing and cshell for remake.It was reported the issue is only behind one ear.The other ear was reported fine.The ear was put on rest to let it heal.The patient would be without one aid until the ear heals.Planned was a return to md for clearance followed by fitting with repaired aid.Patient has allergy to nickel but no other things.

• Brand Name: UNITRON MOXI S7-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 ; laubisrütistrasse 28; stäfa, zürich 8712 ; SZ 8712
• MDR Report Key: 23827167
• Report Number: 3005085999-2025-00045
• Device Sequence Number: 9288476
• Product Code: OSM
• UDI-Device Identifier: 07613389770568
• UDI-Public: (01)07613389770568
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• 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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 050-6913-P2
• Was Device Available for Evaluation?: No
• 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: Not provided
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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: Unknown