NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

PATIENT COMPLAINED OF HEARING LOSS ABOUT 10 HOURS AFTER RECEIVING HER 5TH TMS TREATMENT. PATIENT WAS NOT OFFERED HEARING PROTECTION AND DID NOT WEAR ANY. ENT DETERMINE THE PATIENT HAD MILD TO MODERATE HEARING LOSS AT TWO FREQUENCIES.

Additional Manufacturer Narrative

PATIENT WAS SEEN BY AN ENT AND SOME HEARING LOSS WAS CONFIRMED ALTHOUGH THE CAUSE WAS NOT IDENTIFIED. THE PATIENT WAS NOT OFFERED AND DID NOT WEAR HEARING PROTECTION DURING THE TREATMENTS. THE PATIENT RECEIVED A SERIES OF STEROID INJECTIONS WHICH IMPROVED HER HEARING. AS OF (B)(6) 2025, THE PATIENT HAS ONE INJECTION LEFT, AND HER HEARING IS CLOSER TO BASELINE NOW. DUE TO THE PATIENT REQUIRING STEROID INJECTIONS AND NO OTHER DEFINITIVE CAUSE FOR THE HEARING ISSUES, THIS CASE IS CONSIDERED A SERIOUS INJURY.