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 he has had 7 ear infections since being fitted with current cshells with his audeo i90-sphere devices.The patient is a long-time hearing aid wearer and never had ear infections before wearing the current cshells.He was seen by both his primary care physician (pcp) and an ent.The doctor said he believes the cshells are causing the infections.The hcp did not remember if the pcp or ent said this.The patient has been prescribed multiple rounds of antibiotics to treat the ear infections.This case concerns one patient both ears = 2 cshells (sns: (b)(6)) worn with audeo i90-sphere his (sns: (b)(6)).

• 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: 23623562
• Report Number: 3008848788-2025-00018
• Device Sequence Number: 21095403
• Product Code: OSM
• UDI-Device Identifier: 07613389686630
• UDI-Public: (01)07613389686630
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/28/2025
• Report Date (Section F): 10/28/2025

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/28/2025
• Device Age: 11 MO
• Event Location: Home
• Date Report to Manufacturer: 10/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2025
• 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