Tinnitus management remains challenging, particularly in objective, myoclonic, or somatosensory subtypes where conventional therapies show limited benefit. Botulinum toxin (BTX) has been increasingly investigated as a neuromodulatory treatment option for muscular or neural contributors to tinnitus. This systematic review synthesizes human clinical evidence from 2015 to 2025 regarding the efficacy and safety of BTX for tinnitus treatment. PubMed and Scopus were searched (2015–2025) using predefined keywords: (botulinum neurotoxin OR botulinum toxin OR botox) AND tinnitus. Human studies, English language studies, and original clinical studies were included. Reviews, case reports, animal studies, and studies without tinnitus outcomes after BTX were excluded. Data extraction included tinnitus type, BTX type/dose, injection site, outcome measures, follow-up, and adverse events. Due to heterogeneity, narrative synthesis was performed. Five studies encompassing 257 patients were included. The etiologies of tinnitus included middle ear myoclonic tinnitus (MEMT), hemifacial spasm–associated tinnitus, posterior auricular muscle–related tinnitus, and somatosensory/migraine-associated tinnitus. BTX was administered intratympanically, peristylomastoid, intramuscularly, or into the posterior auricular muscle. All studies reported improvements in tinnitus severity, loudness, or handicap scores. MEMT studies revealed significant reductions in the Tinnitus Handicap Inventory (THI) and Visual Analog Scale (VAS) scores, with 40–100% clinical response. Migraine-associated tinnitus loudness improved by 70–100% in the small tinnitus subset, including complete remission in some patients. No serious adverse events were reported. In selected tinnitus subtypes with suspected neuromuscular or somatosensory mechanisms, BTX appears clinically beneficial and demonstrates a favorable safety profile. The most consistent signals of benefit were observed in myoclonic (including MEMT) and hemifacial spasm–associated tinnitus; however, the current evidence is derived from non-randomized studies with moderate-to-high risk of bias. Larger controlled trials are needed to standardize dosing, define optimal injection targets, and clarify long-term efficacy.
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