ALPHA-STIM TECHNOLOGY

Description of Event or Problem

PT CALLED TO REPORT ADVERSE REACTION TO ALPHA-STIM ELECTRODE. HE STATED HE USED THIS DEVICE AS TREATMENT FOR A PHOBIA OF FLYING. HE TRIED IT ON (B)(6) 2013, AND SAID HE FOLLOWED THE DIRECTIONS AND TRIED THE DEVICE AT THE MINIMUM CURRENT FOR THE MINIMUM AMOUNT OF TIME, WHICH IS 20 MINUTES. SINCE HE USED THE DEVICE, HE HAS BEEN EXPERIENCING SEVERE TINNITUS. HE STATED IT'S BEEN 6 MONTHS AND HE STILL HAS THE TINNITUS AND HE DOESN'T KNOW WHAT TO DO. HE STATED IT'S RUINING HIS LIFE. HE SAID HE'S TRIED ACUPUNCTURE, AND VISITED AN ENT DOCTOR TO HELP HIS CONDITION, BUT NOTHING IS HELPING AND THE DOCTOR DIDN'T FIND ANY PROBLEMS. HE SAID HE FEELS THE COMPANY LIED TO HIM AND THAT TINNITUS WAS NOT LISTED AS A POSSIBLE SIDE EFFECT WHEN USING THE DEVICE. HE MENTIONED THAT HE IS CONSIDERING CONTACTING A LAWYER BECAUSE HE DOESN'T KNOW WHAT ELSE TO DO. HE ALSO STATED HE READ INFO ON THE INTERNET, THAT IT HAS BEEN REPORTED TO THE FDA THAT PEOPLE HAVE EXPERIENCED TINNITUS USING THIS DEVICE. HE IS VERY UPSET THIS IS NOT LISTED AS A POSSIBLE SIDE EFFECT.