TENT-A2: different bimodal neuromodulation settings in a large randomized trial

Record details

Authors: Conlon B, Hamilton C, Meade E, …, Lim HH.
Journal / source: Scientific Reports (2022)
Design: Randomized comparison of stimulation settings (no sham arm)
Sample: 191 fitted, 4 arms
Primary endpoint: Within-arm THI/TFI change
Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: No

What this research found

Paper's own numbers: THI −18.5 points at end of treatment (arms 1–2 average; arm-level range −14.2 to −21.2), −20.2 at 12-month follow-up; TFI −15.3 / −17.3; Cohen's d −0.7 to −1.4.

The manufacturer's oft-quoted '20.3 points' corresponds to the 12-month follow-up THI (20.2 in the paper). As in TENT-A1, no sham: within-arm changes cannot be separated from placebo/natural course.

Limitations and conflicts of interest

No sham arm.

Funding / conflicts: Funded by Neuromod (manufacturer); Lim is CSO.

Primary sources

Used as evidence for

Lenire (bimodal tongue stimulation)

This is an original summary from the Tinnitus Evidence verified database, checked against the primary source — not a reproduction of the publisher's abstract.