Description of Event or Problem · 0
THIS IS MY EXPERIENCE WITH LENIRE: HAD A SUDDEN ONSET OF TINNITUS MID JANUARY OF THIS YEAR. LIVED WITH IT FOR THREE MONTHS. HAD BEEN SEARCHING INTERNET FOR POSSIBLE TREATMENT. CAME ACROSS LENIRE. HAD JUST RECEIVED FDA APPROVAL IN APRIL. SEARCHED CLINICS ACROSS THE US OFF THEIR WEBSITE AND CAME ACROSS A CLINIC IN (B)(6), TINNITUS AND HYPERACUSIS CLINIC. SPOKE TO DR (B)(6) AND HE STATED THEY WERE HAVING A SEMINAR THE FOLLOWING TUESDAY ON LENIRE AND THAT I COULD COME AND ATTEND. HE SAID HE COULD GET ME FITTED AND I COULD TAKE A DEVICE HOME WITH ME. WE FLEW ACROSS THE COUNTRY FROM (B)(6) WITH HOPES OF GETTING RELIEF FOR MY TINNITUS. WENT TO THE CLINIC AND WAS FITTED PRIOR TO THE SEMINAR FOR THE DEVICE BY DR (B)(6). DURING THE MEETING WITH THE DR (B)(6) AND THE LENIRE REP THERE WAS NO MENTION OF THE POSSIBILITY OF A LONG TERM ADVERSE EFFECT OR EVEN THAT A TEMPORARY WORSENING COULD HAPPEN FROM USING THE DEVICE. NO PAPER WORK GIVEN DISCLOSING ANY POSSIBLE ADVERSE EFFECTS OTHER THAN THE LENIRE MANUAL. IT ONLY MENTIONED THE POSSIBILITY OF A TEMPORARY SPIKE I ASSUMED THE DOCTOR OR THE LENIRE REP WOULD HAVE BROUGHT IT UP DURING THE MEETING. PURCHASED THE LENIRE DEVICE FOR (B)(6). THEN ATTENDED THE SEMINAR. ONCE AGAIN NO MENTION OF ADVERSE EFFECTS OR TEMPORARY SPIKE UNTIL A WOMAN IN THE SEMINAR BROUGHT IT UP. THEN IT WAS DISCLOSED. BROUGHT THE TREATMENT HOME AND USED IT FOR ONE WEEK. STARTED TO EXPERIENCE A SEVERE INCREASE IN MY TINNITUS. STOPPED THE TREATMENT. AFTER TRYING TO WORK WITH THE CLINIC THROUGH THIS SEVERE INCREASE OF MY TINNITUS FOR THE LAST SIX MONTHS THINGS HAVE NOT GOTTEN BETTER. ALSO RECEIVED A MESSAGE FROM THE WOMAN AT THE SEMINAR THAT SHE AS WELL HAD EXPERIENCED THE SAME EFFECT AND HER TINNITUS APPEARS TO BE PERMANENTLY WORSE. THE CLINIC SINCE HAS REFUNDED ME MY MONEY FOR THE DEVICE OTHER THAN A (B)(6) I TOLD THE DR HE COULD KEEP FOR HIS TIME. HAVE REACHED OUT TO LENIRE FOR HELP AND THEY ADVISED I WORK THINGS OUT WITH MY PROVIDER BUT THEY WOULD LOOK INTO IT. AT THE END OF THE DAY MY TINNITUS IS MUCH WORSE STILL AFTER USING LENIRE. THERE SEEMS TO BE NO RELIEF INSIGHT. IN MY OPINION IS THAT LENIRE IS NOT A SAFE THERAPY FOR PATIENTS WITH TINNITUS. IF I HAD BEEN WARNED BY THE CLINIC OR LENIRE THAT THERE WAS A CHANCE OF A SEVERE PERMANENT WORSENING OF MY TINNITUS I WOULD HAVE NEVER TAKEN THE CHANCE. I ALSO HAVE SINCE HAVE DONE MORE RESEARCH INCLUDING HAVING AN APPOINTMENT WITH A WORLD RENOWN NEUROSURGEON WHO SPECIALIZES IN TINNITUS. HE EXPLAINED THAT HE ONCE USED LENIRE AT HIS CLINIC BUT STOPPED USING IT AS PATIENTS WERE HAVING SEVERE ADVERSE REACTIONS TO IT. IT WAS EXPLAINED TO ME THAT SINCE MY WORSENING SYMPTOMS FROM LENIRE HAVE LASTED MORE THEN ONE MONTH I HAVE A 20% CHANCE I WILL RECOVER FROM THE DAMAGE CAUSED BY LENIRE WITH OUT MEDICAL INTERVENTION AND A 60-70% CHANCE I WILL RECOVER WITH MEDICAL INTERVENTION. AFTER INVESTING (B)(6) AND TIME AND TRAVEL IN HOPES OF FINDING SOMETHING THAT COULD HAVE HELPED ME ONLY TO HAVE MY CONDITION TO BE MADE MUCH WORSE AND WHAT APPEARS TO BE PERMANENT DAMAGE CAUSED TO MY HEALTH AND WELL BEING HAS BEEN DEVASTATING! ALSO SINCE HAVING MY EXPERIENCE MORE AND MORE PEOPLE ARE EXPERIENCING THE SAME THING YOU CAN GO ON LENIRE TINNITUS SUPPORT GROUP ON FACEBOOK OR TINNITUS TALK ONLINE AND SEE ALL THE BAD EXPERIENCES PEOPLE ARE HAVING FROM USING THIS THERAPY. PLEASE PLEASE STOP THIS FROM HAPPENING TO MORE PEOPLE. THE THERAPY IS DANGEROUS AND MANY MORE PEOPLE WILL BE HURT WITHOUT THE FDA INVOLVEMENT.