The effect of caffeine on tinnitus: Randomized triple-blind placebo-controlled clinical trial

PLoS One. 2021 Sep 20;16(9):e0256275. doi: 10.1371/journal.pone.0256275. eCollection 2021.


Objective: To test the hypothesis that caffeine can influence tinnitus, we recruited 80 patients with chronic tinnitus and randomly allocated them into two groups (caffeine and placebo) to analyze the self-perception of tinnitus symptoms after caffeine consumption, assuming that this is an adequate sample for generalization.

Methods: The participants were randomized into two groups: one group was administered a 300-mg capsule of caffeine, and the other group was given a placebo capsule (cornstarch). A diet that restricted caffeine consumption for 24 hours was implemented. The participants answered questionnaires (the Tinnitus Handicap Inventory-THI, the Visual Analog Scale-VAS, the profile of mood state-POMS) and underwent examinations (tonal and high frequency audiometry, acufenometry (frequency measure; intensity measure and the minimum level of tinnitus masking), transient otoacoustic emissions-TEOAE and distortion product otoacoustic emissions-DPOAE assessments) at two timepoints: at baseline and after capsule ingestion.

Results: There was a significant change in mood (measured by the POMS) after caffeine consumption. The THI and VAS scores were improved at the second timepoint in both groups. The audiometry assessment showed a significant difference in some frequencies between baseline and follow-up measurements in both groups, but these differences were not clinically relevant. Similar findings were observed for the amplitude and signal-to-noise ratio in the TEOAE and DPOAE measurements.

Conclusions: Caffeine (300 mg) did not significantly alter the psychoacoustic measures, electroacoustic measures or the tinnitus-related degree of discomfort.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Audiometry, Pure-Tone / methods*
  • Caffeine / pharmacology*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Otoacoustic Emissions, Spontaneous / physiology*
  • Psychoacoustics*
  • Surveys and Questionnaires
  • Tinnitus / drug therapy*
  • Tinnitus / psychology


  • Caffeine

Associated data

  • figshare/10.6084/m9.figshare.12962684

Grants and funding

The authors received no specific funding for this work.