FDA Adverse Event Malfunction Summary report: N

MINIRITE R

MDR report key: 23479124 · Received November 5, 2025

Report

Report Number
MW5178541
Event Type
Malfunction
Date Received
November 5, 2025
Date of Event
August 14, 2024
Report Date
October 31, 2025
Manufacturer
OTICON INC.
Product Code
OSM
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PURCHASED HEARING AIDS (B)(6) 2021 HAD A PROBLEM WITHIN A FEW WEEKS OF PURCHASE WHICH HAD THEM SENT TO THE MFG & THEN HAD SAME PROBLEM THAT NEEDED TO HAVE THEM RETURNED TO THE MFG FOR REPAIR WHICH BEGAN AGAIN IN EARLY 2024 BUT WAS TOLD THE PROVIDER WOULD NOT DEAL WITH THEM UNLESS I PAID A FEE FOR THE VISIT EVEN BEFORE THEY WOULD SEE WHAT WAS WRONG. THEN I CONTACTED OTICON THE MFG. WHO QUOTED A LEGAL STATEMENT TO ME THAT OTICON BY LAW COULD NOT PROVIDE ANY SERVICES TO ME PERSONALLY & THAT I MUST GO THROUGH A PROVIDER FOR ASSISTANCE. OTICON ALSO STATED THE WARRANTY WAS FOR 3 YEARS PLUS THERE WAS A 2 YEAR EXTENDED WARRANTY THAT WAS OFFERED. WHEN CONTACTING THE PROVIDER THEY SAID THEY WANTED TO BE PAID BEFORE SEEING ME, BUT THEN SAID THEY WOULD ACCEPT $350 TO SEND THE AIDS BACK FOR REPAIRS BUT ALSO STATED THAT THERE WASN'T ANY EXTENDED WARRANTY FROM OTICON. OTICONS WEBSITE STATES THE FOLLOWING INFORMATION: EXTENDED WARRANTIES ARE AVAILABLE FOR THE 3RD, 4TH AND 5TH YEAR BEYOND THE FITTING DATE OF THE PROCESSORS. ADDITIONAL YEARS OF LOSS, THEFT AND DAMAGE COVERAGE CAN BE PURCHASED WITH AN ADDITIONAL REPAIR WARRANTY AT ANY TIME UP TO THE EXPIRATION OF THE WARRANTY PERIOD." THERE IS ALSO A SCHEME WITH THE HEALTH CARE INSURANCE INDUSTRY REGARDING THE ABOVE. ALTHOUGH 1 YEAR HAS ELAPSED FROM MY 2ND COMPLAINT MY COMPLAINT ABOVE STILL STANDS. WITH AN EXPLANATION AS TO WHY I AM NOW MAKING THIS COMPLAINT IN THE 4TH YEAR OF OWNERSHIP. PT CODE: 4582. DEVICE CODE: 3023. REF REPORT: MW5178562.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2280885 MINIRITE R HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION OSM OTICON INC. MINIRITE R (RUBY)

Patients

Seq Age Sex Outcome Treatment
1 NA Male