FDA Adverse Event
Malfunction
Summary report: N
HEARING AID
MDR report key: 23495346
·
Received November 6, 2025
Report
- Report Number
- MW5178568
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- October 25, 2025
- Report Date
- November 2, 2025
- Manufacturer
- PHONAK / SONOVA AG
- Product Code
- QUH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NJ, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
MYPHONAK APP FOR HEARING AID IS MALFUNCTIONING ON SUPPORTED IPHONE (IPHONE SE 2020) AND IOS (26.0.1) ALLOWING THE APP TO DOWNLOAD. CANNOT USE HEARING AIDS NOW. CONTACTED COMPANY AND THEY ARE REFUSING TO FIX THE APPLICATION RENDERING THE HEARING AID DEVICES USELESS. I AM FORCED TO BUY A NEW PHONE OR HEARING AIDS AT AN EXTREME COST. THIS PRODUCT IS SUPPOSED TO WORK WITH THIS IPHONE AND IOS COMBINATION ACCORDING TO THE MANUFACTURER. PT CODE: 4582. DEVICE CODE: 2588. REFERENCE REPORT: MW5178569.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2177497 | HEARING AID | SELF-FITTING AIR-CONDUCTION HEARING AID, OVER THE COUNTER | QUH | PHONAK / SONOVA AG | AUDEO L90-RT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |