NEUROSTAR ADVANCED THERAPY SYSTEM
Received Feb 13, 2026 · Event occurred Jan 12, 2026
Report 3004824012-2026-00005 · MDR key 24339966
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
21 YR · Female
- Tinnitus
- Partial Hearing Loss
Narrative
Additional Manufacturer Narrative
PATIENT HAD NOT WORN EARPLUGS UNTIL SHE TRIED USING THEM ON THE 10TH TREATMENT. PATIENT EXPERIENCED A TINNITUS EPISODE ON THE 11TH TREATMENT SO WILL NOT RECEIVE ANY FURTHER TREATMENTS UNTIL SEEN BY AN ENT. PATIENT DENIED HAVING ANY TINNITUS PRIOR TO THESE EPISODES. SHE REPORTS A SLIGHT SUBJECTIVE WORSENING OF HEARING WHILE AT WORK. HOWEVER, THE PATIENT HAS NOT FOLLOWED UP TO SCHEDULE AN APPOINTMENT WITH THE ENT. PROVIDER HAS NO CLEAR CAUSE TO ATTRIBUTE THE SYMPTOMS. PER PATIENT, TINNITUS AND SUBJECTIVE HEARING LOSS HAVE NOT AFFECTED HER REGULAR ROUTINE BUT IS BOTHERSOME.
Description of Event or Problem
PRACTICE REPORTED A FEMALE PATIENT STARTED TO EXPERIENCE NEW ONSET BILATERAL TINNITUS ON (B)(6) 2026 WHILE AT WORK AND AGAIN 2X THAT EVENING. IT OCCURRED FOR THE FIRST TIME DURING TREATMENT ON (B)(6) 2026.