Sodium Fluoride for Otosclerosis: A Systematic Review and Meta-analysis
Jonathan M Hughes1,2, Neeti Gandra1,3, Shaun A Nguyen1
1Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.
Objective:
Sodium fluoride has historically been used to slow progression of hearing loss in patients with otosclerosis, yet the contemporary clinical benefit and optimal daily dose remain unclear. We performed a systematic review and meta-analysis to evaluate audiologic outcomes associated with fluoride therapy.
Data Sources:
PubMed, Scopus, CINAHL, and Cochrane were searched from inception through July 23, 2025.
Review Methods:
Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines were followed. Randomized and observational studies reporting pre-treatment and post-treatment hearing outcomes in patients with otosclerosis treated with sodium fluoride were included. Outcome measures included continuous variables (means), proportions (%), and relative risks (RRs) with 95% confidence intervals.
Results:
A total of 10 studies comprising 2352 patients were included. Pooled all-dose analysis showed that fluoride was associated with superior hearing stabilization (RR 1.6; 95% CI, 1.0-2.5) and reduced deterioration (RR 0.2; 95% CI, 0.2-0.3) compared with controls. Hearing improvement or stabilization occurred in 96.4% (95% CI, 90.7%-99.4%) receiving high-dose fluoride, 83.8% (95% CI, 57.4-98.6%) receiving low-dose fluoride, and 57.2% (95% CI, 30.7%-81.7%) of untreated controls. Patients not receiving fluoride therapy, including placebo controls, experienced deterioration at a rate of 27.1% (95% CI, 2.3%-65.4%).
Conclusion:
For patients with otosclerosis, high-dose fluoride was associated with a protective effect against hearing loss, and low-dose therapy was associated with stabilization. Patients not receiving fluoride experienced higher rates of hearing loss and lower rates of stabilization. Despite modest evidence quality and variable audiologic definitions, findings support selective use in patients for whom medical management is preferred.