Description of Event or Problem · 0
THE COMPANY STATES IN ITS FINDINGS THAT WHILE THE DEVICE WILL NOT CURE TINNITUS THERE IS AN 80% CHANCE THAT YOUR SYMPTOMS WILL BE DIMINISHED. THEY ALSO SAY THERE IS A 20% CHANCE THAT THERE WILL BE NO CHANGE. THEY NEVER SAY THAT YOUR CONDITION WILL GET WORSE. THEY DO SAY THAT YOU MIGHT EXPERIENCE SOME WORSENING OF YOUR CONDITION BUT THAT WILL DISSIPATE AFTER A WEEK OR TWO. I USED THE LENIRE DEVICE AS PRESCRIBED BY MY DOCTOR, TWICE A DAY FOR 30 MINUTES. I DID THIS FOR 4 MONTHS, I FINALLY HAD TO STOP BECAUSE MY CONDITION GOT SO BAD. I CONTACTED MY DOCTOR HE SAID TO RETURN THE DEVICE AND HE WOULD RECALIBRATE IT. A WEEK LATER I STARTED UP AGAIN BUT AFTER ANOTHER WEEK THERE WAS NO CHANGE. I HAD TO STOP AGAIN. I DID SOME RESEARCH AND FOUND A BLOG WHERE PEOPLE USING LENIRE HAD THE SAME RESULT. THEIR CONDITION GOT WORSE AND THEY HAD TO STOP. MY PROBLEM IS THAT THE COMPANY NEVER SAID THAT THIS WOULD HAPPEN. THEY NEVER SAID YOUR CONDITION WOULD GET WORSE AND STAY THAT WAY. I WOULD NEVER HAVE SPENT $(B)(6) FOR A DEVICE THAT COULD MAKE MY CONDITION WORSE. EVEN IF THAT WAS ONLY A ONE IN TEN CHANCE. TINNITUS IS A TERRIBLE CONDITION, I HAD HABITUATED TO THE LEVEL OF NOISE MY TINNITUS CAUSED NOW I HAVE A NOISE LEVEL THAT IS TWICE AS LOUD. I WOULD RECOMMEND TO THE FDA THAT YOU RESCIND YOUR APPROVAL. THIS DEVICE IS DANGEROUS, IT REQUIRES A LOT MORE STUDY BEFORE IT SHOULD BE APPROVED. HERE IS A LINK WHERE "OTHER" PEOPLE WHO TRIED THE DEVICE HAD SIMILAR PROBLEMS. HTTPS://WWW.TINNITUSHUB.COM/HERES-WHY-THE-JURYS-STILL-OUT-ON-LENIRE/(B)(6).