MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO I90-SPHERE; HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL

Model Number	050-1029-P7
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Ear infection (4813)
Type of Reportable Event	Serious Injury
Event or Problem Description
It has been brought to manufacturer's attention that the patient is reporting recurrent otitis externa while using a cshell 6.0 with his hi (auedo i90-sphere).He uses a cshell on his left ear and a dome on the other side.He previously used domes with his hearing aids and did not have an issue.The patient reports "every 6 weeks he gets another (outer) ear infection" and this began when he started using the cshell (b)(6) 2024.The provider hypothesizes this may because it fits deeper than the domes he was using.Symptoms the patient has been experiencing are "white, squamous debris" as observed with otoscopy and he has experienced itching.The patient has been seeing his primary physician to have ear "flushed out" and has seen ent "for treatment".The ent has been prescribing "antibiotic drops" for treatment.This has also led the patient leaving the hearing aid out for periods of time while the condition resolves.

• Brand Name: PHONAK AUDEO I90-SPHERE
• Common Device Name: HEARING AID, AIR-CONDUCTION, RECEIVER-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich ,che 8712 ; SZ 8712
• MDR Report Key: 23304352
• Report Number: 3008848788-2025-00012
• Device Sequence Number: 10037287
• Product Code: OSM
• UDI-Device Identifier: 07613389686630
• UDI-Public: (01)07613389686630
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2025
• Report Date (Section F): 09/16/2025

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: 050-1029-P7
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/16/2025
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• 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