Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss

J Laryngol Otol. 2009 Jan;123(1):54-60. doi: 10.1017/S0022215108003770. Epub 2008 Oct 17.


Objective: To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss.

Design: Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial.

Subjects: Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient's blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates.

Results: Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p < 0.05). Mean hearing gains, pure tone averages, speech reception thresholds and subjective recovery rates were significantly better in ozone-treated patients compared with placebo-treated patients (p < 0.05).

Conclusion: Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Blood Transfusion, Autologous / methods*
  • Double-Blind Method
  • Female
  • Hearing Loss, Sensorineural / therapy*
  • Hearing Loss, Sudden / therapy*
  • Humans
  • Male
  • Middle Aged
  • Ozone / administration & dosage
  • Ozone / blood
  • Ozone / therapeutic use*
  • Recovery of Function
  • Severity of Illness Index
  • Statistics as Topic
  • Treatment Outcome
  • Young Adult


  • Ozone