MAUDE Adverse Event Report: SONOVA AG PHONAK BOLERO M50-PR; HEARING AIDS, BEHIND-THE EAR

Model Number	0500675P5
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer did not receive any additional information from the hcp, therefore it is unknown what pre-existing allergies the patient has, how soon after the start of hearing aid use the symptoms manifested itself, whether any cleaning agents were used on the hearing aid that could contribute to the allergic reaction.In the initial complaint, apart from the incident notification, the hcp enquired about the charging contacts and the housing pins.Charging contacts and housing pins of phonak bolero m-pr are made from a surgical grade titanium alloy (meeting astm f136 requirements).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.Risk file of the device already coveres risk associated with biocompatibility of the device.This is the final report.
Event or Problem Description
The manufacturer was notified about a patient showing a strong reaction in the area where the hearing aid is worn with scaly, reddened, itchy skin.The patient only wears a hearing aid monaurally, the reaction is probably due to wearing the hearing aid, as there are no signs of it on the other ear.The patient has been prescribed an ointment by the ent.

• Brand Name: PHONAK BOLERO M50-PR
• Common Device Name: HEARING AIDS, BEHIND-THE EAR
• 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: 22641703
• Report Number: 3005085999-2025-00021
• Device Sequence Number: 14750932
• Product Code: OSM
• UDI-Device Identifier: 07613275689721
• UDI-Public: (01)07613275689721
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 0500675P5
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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