Description of Event or Problem · 0
I AM CONCERNED ABOUT THE NEUROMOD DEVICES LENIRE DEVICE FOR TREATMENT OF TINNITUS. I USED IT FOR SIX WEEKS UNDER GUIDANCE FROM A TRAINED AUDIOLOGIST LICENSED TO USE THE LENIRE DEVICE. AFTER SIX WEEKS OF DAILY USE, AS PER PRESCRIBED PROTOCOLS, MY TINNITUS WAS SIGNIFICANTLY WORSE. WITH APPROVAL OF MY AUDIOLOGIST, I STOPPED THE TREATMENT. MY CONDITION HAS IMPROVED BUT NOT TO THE POINT WHERE I HAD BEEN BEFORE BEGINNING THE TREATMENT ON JUNE 25. I DID MY RESEARCH BEFORE BEGINNING THE TREATMENT. I WAS TOLD THAT I HAD A RELATIVELY LOW THE SCORE, BUT I BEGAN TREATMENT KNOWING THAT IT MIGHT NOT IMPROVE MY CONDITION, BUT CERTAINLY WOULD NOT WORSEN IT. I WAS WRONG. IT WORSENED MY TINNITUS CONSIDERABLY. I BELIEVE THAT THE FOOD AND DRUG ADMINISTRATION SHOULD FURTHER INVESTIGATE FAILURES OF THE LENIRE DEVICE. THERE HAS BEEN A LOT OF HYPE BY GENERAL NEWS MEDIA AND BY LENIRE ITSELF ABOUT EFFICACY OF THE DEVICE AND SELECTED PATIENT IMPROVEMENT. HOWEVER, NOT ENOUGH HAS BEEN DONE BY LENIRE TO REVIEW FAILURES, PARTICULARLY THOSE WHERE THE TINNITUS CONDITION HAS BEEN WORSENED BY USE OF THE DEVICE. THE SECOND ASPECT OF MY COMPLAINT IS WITH THE FDA ITSELF. BY CLASSIFYING IT AS A MEDICAL DEVICE, YOU FORBID RE-USE OF THE LENIRE DEVICE. YET, IT IS NOTHING BUT AN AUDIO PLAYBACK MACHINE. NEITHER THE LENIRE DEVICE NOR ITS ASSOCIATED MEDICAL TREATMENT ARE COVERED BY INSURANCE. THUS, THERE IS A VERY HIGH BAR FOR ACCESS TO THE TREATMENT BECAUSE OF ITS MASSIVE INVESTMENT - $(B)(6) IN MY CASE ¿ FOR A TREATMENT WITH NO GUARANTEE OF SUCCESS. WHEN FDA DISALLOWS DEVICE RESALE (EVEN IF SOLD BACK TO NEUROMOD), IT RESTRICTS ACCESS TO THE TREATMENT FOR THOSE FOR WHOM IT MIGHT HELP.