FDA Adverse Event Malfunction Summary report: N

LENIRE DEVICE

MDR report key: 19089401 · Received April 10, 2024

Report

Report Number
MW5153731
Event Type
Malfunction
Date Received
April 10, 2024
Date of Event
April 5, 2024
Report Date
April 8, 2024
Manufacturer
NEUROMOD DEVICES LTD.
Product Code
QVN
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I PURCHASED THE LENIRE DEVICE FROM AN AUDIOLOGY CLINIC LOCATED IN THE (B)(6) AREA. AFTER USING THE DEVICE AS INSTRUCTED BY THE CLINIC FOR THE SUGGESTED 12-WEEK PERIOD, PLUS AN ADDITIONAL 4+ WEEKS, THE RESULTS WERE DISAPPOINTING. I DID NOT EXPERIENCE A SIGNIFICANT IMPROVEMENT WITH MY TINNITUS SYMPTOMS. I REGRET SPENDING THE APPROXIMATELY (B)(6) FOR THE LENIRE DEVICE. AS A SIDE NOTE, I HAVE BEEN IN CONTACT WITH ANOTHER CLIENT OF THE (B)(6) CLINIC. SHE ALSO PURCHASED THE LENIRE DEVICE AND STATED TO ME THAT HER RESULTS WERE SIMILAR TO MINE. I FOUND THE EMPLOYEES OF THE CLINIC I PURCHASED THE DEVICE FROM TO BE INTELLIGENT AND CARING, SO MY EXPERIENCE IS NO REFLECTION ON THEM. WHILE I WAS TOLD IN ADVANCE BY THE CLINIC THAT THERE IS NO TRIAL PERIODS AND NO REFUNDS FOR THE LENIRE DEVICE, I STILL FIND THIS WAS ODD BECAUSE I PURCHASED HEARING AIDES (IN HOPE THEY WOULD IMPROVE MY TINNITUS) FROM A LICENSED HEARING AIDE SPECIALIST AND THEY OFFERED A TRIAL PERIOD WITH A FULL REFUND IF I WAS NOT SATISFIED WITH THE HEARING AIDES. AS IT TURNED OUT, I DID RETURN THE HEARING AIDES WITHIN THE TRIAL PERIOD AND I DID RECEIVE A FULL REFUND. I WISH THE LENIRE DEVICE HAD THE SAME RETURN POLICY AS THOSE HEARING AIDES.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
808779 LENIRE DEVICE COMBINED ACOUSTIC AND ELECTRICAL EXTERNAL STIMULATION DEVICE FOR THE RELIEF OF T QVN NEUROMOD DEVICES LTD. CR/201

Patients

Seq Age Sex Outcome Treatment
1 72 YR Male HEARING AIDS.