MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO P90-RL; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	050-0773
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer conducted a follow up with the initial reporter to gather more information on the incident.The hcp reported that the patient needed to be seen at urgent care for a cerustop wax guard in his left ear canal.Wife is a retired rn so she has an otoscope at home but was unable to get it out.The hcp reports cshells did not retain wax guard from the initial fitting.It first happened in the hcps office and the cp was able to remove it and instructed the patient to press down on the wax guard when inserting a new one to be sure it is in the cshell all the way.The patient did not suffer any medical symptoms in the course of this event.The patient has recovered and continues to wear the current his and cshells but was advised not to use the wax guards in the current molds.Yes.Audiologist ordered new cshell molds.Affected left cshell sn: (b)(6).The manufacturer has checked the modelling files of the custom-made earpiece (cshell) subject to this incident and confirms the modelling was done according to the order of the hcp.There were no issues identified with how the tip of the shell was design in regard to the placement of the cerustop waxguard.Manufacturer confirms that cerustop wax guard is a detachable part by design.Its function is to protect the receiver from earwax and debris accumulation.Cerumen filers need to be replaced regularly to prevent acoustic sound deterioration.An applicable risk on the detachable parts of the device remaining in the ear canal is present in the risk assessment of this device.Risk control measures, including appropriate warning in the user guide, are implemented.The user guide also contain a dedicated instruction on the filter replacement method.The manufacturer checked service records.There were no services to these devices prior to this event.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 the hcp reported she noticed the wax guards did not go easily into the when she went to fit them with the patient.The patient ended up having to go to urgent care because the wax guard fell out and got stuck in his ear.

• Brand Name: PHONAK AUDEO P90-RL
• 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 ; laubistuetistrasse 28; staefa, zurich 8712 ; SZ 8712
• MDR Report Key: 23714503
• Report Number: 3005085999-2025-00041
• Device Sequence Number: 16013662
• Product Code: OSM
• UDI-Device Identifier: 07613389301113
• UDI-Public: (01)07613389301113
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/10/2025

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: 050-0773
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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