NEUROSTAR ADVANCED THERAPY
Received Feb 18, 2026 · Event occurred Jan 14, 2026
Report 3004824012-2026-00006 · MDR key 24378731
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Male
- Tinnitus
Narrative
Additional Manufacturer Narrative
ENT REPORT WAS OBTAINED ON (B)(6) 2026. THIS REPORT INDICATES THAT THE PATIENT HAS NORMAL TO MODERATE SENSORINEURAL HEARING LOSS IN THE RIGHT EAR AND NORMAL SLOPING TO A MILD TO MODERATE SENSORINEURAL HEARING LOSS IN THE LEFT EAR. PROVIDER FEELS THAT TINNITUS IS MORE LIKELY RELATED TO HIGH-FREQUENCY SENSORINEURAL HEARING LOSS THAN FROM TMS. THE PATIENT'S EMPLOYMENT INVOLVES A POTENTIALLY LOUD WORK ENVIRONMENT ON A REGULAR BASIS. PATIENT WAS CLEARED BY THE ENT TO CONTINUE TMS IF THEY CHOOSE TO DO SO. PATIENT WAS SEEING BENEFIT FOR THEIR DEPRESSION AND OCD WHEN THEY ORIGINALLY STOPPED TREATMENT.
Additional Manufacturer Narrative
THE PROVIDER REPORTED THAT A PATIENT WAS EXPERIENCING NEW BILATERAL TINNITUS. THE PATIENT SAID THEY WERE HEARING A HIGH FREQUENCY SOUND IN BOTH EARS. THIS DOES NOT INTERFERE WITH THEIR DAILY ROUTINE OR ARE ABLE WORK. PATIENT SAID THAT IT VARIES IN PITCH AND FREQUENCY BUT MAY BE A LITTLE BETTER SINCE PAUSING TMS TREATMENT. PATIENT WOULD LIKE TO CONTINUE WITH TMS BUT PROVIDER WANTS TO WAIT UNTIL THEY HAVE A COMPLETE WORK UP WITH THE SECOND ENT. PATIENT HAS SEEN AN URGENT CARE PROVIDER AND ONE ENT SO FAR AND BOTH STATED THAT THE FINDINGS WERE ALL NORMAL OR NOT INFORMATIVE AS TO THE REASON FOR THE NEW TINNITUS.
Description of Event or Problem
THE PROVIDER REPORTED THAT A PATIENT ON THEIR 12TH OCD/MDD TMS SESSION WAS EXPERIENCING BILATERAL HIGH FREQUENCY TINNITUS THAT HAD BEEN UNREMITTING FOR SEVERAL DAYS.