TENT-A1: bimodal sound + tongue stimulation for tinnitus
Record details
- Authors: Conlon B, Lim HH, et al.
- Journal / source: Science Translational Medicine (2020)
- Design: Randomized double-blinded comparison of three stimulation parameter sets
- Sample: 326
- Primary endpoint: Within-arm THI and TFI change at end of treatment
- Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: No
What this research found
Pre-specified primary result: within-arm THI improvement, effect sizes d = −0.87 to −0.92 across the three arms (≈14 THI points pooled), p<0.001 — but the arms did not differ from each other, and no arm was a sham.
The widely quoted '86.2% improved at 12 weeks / 80.1% sustained at 12 months' figures come from manufacturer materials, count ANY improvement among compliant completers (not clinically meaningful responders), and could not be verified in the paper itself. Because every arm received active treatment, the trial cannot separate device effect from placebo/natural course.
Limitations and conflicts of interest
No sham or no-treatment arm; identical results across arms; headline percentages are company-derived.
Funding / conflicts: Funded by Neuromod Devices (manufacturer).
Primary sources
Used as evidence for
This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.