NEUROSTAR ADVANCED THERAPY
Received Jul 2, 2026 · Event occurred Dec 11, 2025
Report 3004824012-2026-00017 · MDR key 25697362
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Partial Hearing Loss
Narrative
Additional Manufacturer Narrative
PATIENT COMMENTED ON SOCIAL MEDIA THAT PEOPLE SHOULD NOT DO TMS. NEURONETICS (NNI) REACHED OUT 3X TO THE INDIVIDUAL REQUESTING THEY CONTACT NNI DIRECTLY. AFTER THE 3RD OUTREACH, THE PATIENT RESPONDED THAT SHE HAD PROFOUND HEARING LOSS AND HAS TO WEAR HEARING AIDS, AS WELL AS PROVIDING NNI WITH HER PERSONAL EMAIL. NNI EMAILED THE PATIENT 3 TIMES OVER A FEW WEEKS BUT NO RESPONSE FROM THE PATIENT. NNI WAS ABLE TO LOCATE THE TMS PROVIDER CLINIC THAT TREATED THE PATIENT AND SPOKE WITH THEM. THE PATIENT DID NOT COMPLAIN ABOUT ANY HEARING LOSS DURING TREATMENT AND DECLINED EARPLUGS MORE OFTEN THAN SHE WORE THEM. THE PATIENT'S EXPOSURE TO NOISE LEVELS BASED ON HER TREATMENT POWER LEVEL WAS BELOW OSHA'S MANDATORY EAR PROTECTION LEVEL (DB) FOR THE PERIOD OF TIME EACH TREATMENT WAS DELIVERED. THE PATIENT COMPLETED TMS TREATMENT ON (B)(6) 2025 AND HAD A POST-TREATMENT ASSESSMENT ON (B)(6) 2025 AT WHICH POINT SHE NOTED HAVING HEARING ISSUES. SINCE THE PATIENT DID NOT RESPOND TO NNI TO PROVIDE FURTHER INFORMATION, IT IS UNCLEAR WHAT OTHER FACTORS MAY HAVE CONTRIBUTED OR CAUSED THE HEARING ISSUES (SUCH AS THE PATIENT'S AGE (74 YRS), BASELINE HEARING TESTS, OTHER HEALTH ISSUES, OR SOUND EXPOSURES, ETC). HEARING LOSS IS NOT AN EXPECTED TMS SIDE EFFECT, ESPECIALLY WHEN HEARING PROTECTION IS WORN. NNI IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
PATIENT MADE A COUPLE SOCIAL MEDIA COMMENTS ON A NEUROSTAR POST STATING, "DON'T DO IT." OR SIMILAR. NEURONETICS (NNI) REACHED OUT 3 TIMES OVER SOCIAL MEDIA REQUESTING THE PATIENT CONTACT NNI. AFTER THE 3RD NNI OUTREACH, THE PATIENT PROVIDED THEIR EMAIL ADDRESS FOR FURTHER CONTACT. NNI EMAILED 3 TIMES WITHOUT ANY RESPONSE FROM THE PATIENT.