Reversing synchronized brain circuits using targeted auditory-somatosensory stimulation (bisensory device RCT)

Record details

Authors: Jones GR, …, Shore SE.
Journal / source: JAMA Network Open (2023)
Design: Double-blind randomized crossover (6-week active vs 6-week auditory-only control)
Sample: 99 randomized
Primary endpoint: CO-PRIMARY: TFI change AND tinnitus loudness level (psychoacoustic loudness matching, dB SL). THI was secondary.
Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: Yes

What this research found

TFI after active treatment: −12.0 points (ITT, p<.001), −13.2 per-protocol (n=56) — within-participant changes at week 6; the control block did not produce clinically significant decreases. Loudness matching (co-primary) MISSED significance in the ITT analysis at week 6: −5.8 dB SL (p=.08) / −7.2 dB PP (p=.03) at week 6, deepening to −10.9 ITT (p=.001) / −14.1 PP (p<.001) by week 12 of the second active phase.

≥13-point TFI responders: 65% per-protocol / 53% ITT after active treatment vs 25%/20% after control. All change figures are within-participant during the bisensory blocks, not active-minus-control differences. Somatic tinnitus only. NIH-funded (RF1-MH114244).

Limitations and conflicts of interest

Single-center; per-protocol n=56; somatic tinnitus subtype only; COVID disruptions.

Funding / conflicts: NIH-funded; Shore and Martel are Auricle Inc cofounders with equity/patent interests (disclosed).

Primary sources

Used as evidence for

Auricle bisensory stimulation (Susan Shore device)

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