Smartphone tinnitus app: double-blind sham-controlled RCT (Japan)
Record details
- Authors: Wasano K, Kawasaki T, Goto F, et al.
- Journal / source: JAMA Otolaryngology–Head & Neck Surgery (2026)
- Design: Double-blind sham-controlled RCT, 3 centers
- Sample: 60
- Primary endpoint: THI at week 16
- Randomized: Yes · Sham/placebo-controlled: Yes · Independent of the manufacturer: No
What this research found
At week 16: THI −16.8 (active) vs +3.6 (sham — the sham arm slightly worsened, which flatters the difference); between-group −20.4 points (95% CI −28.2 to −12.6); meaningful improvement 70% vs 27%.
Per the authors, the first DOUBLE-BLIND sham-app-controlled RCT of a tinnitus digital therapeutic (earlier app RCTs were single-blind). Registration jRCTs032230359.
Limitations and conflicts of interest
N=60, single country, industry-sponsored.
Funding / conflicts: Sponsored by Kyorin Pharmaceutical; several authors received sponsor fees.
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.