Oto app RCT vs waitlist (Flinders University)
Record details
- Authors: Mui B, Muzaffar J, Chen J, Bidargaddi N, Shekhawat GS
- Journal / source: Speech, Language and Hearing (2025)
- Design: Unblinded RCT vs waitlist
- Sample: 96 randomized (arm split per paper; overall dropout 21%)
- Primary endpoint: TFI at 6 months
- Randomized: Yes · Sham/placebo-controlled: No · Independent of the manufacturer: No
What this research found
Between-group TFI improvement at 6 months: 9 points (95% CI [2, 16], p=.006) — verified against the paper's abstract. Significant time×treatment interaction at 6 months (p<.001, d=0.62) and 9 months (p=.002, d=0.54). Clinically meaningful (≥13-point) TFI reduction: 32% vs 12% at 6 months (z=2.20, p=.030). Overall dropout 21%.
A previous version of this record misreported the 6-month result as "16 points (p=.002, 95% CI 6–25)" — 16 is the upper bound of the actual CI [2, 16] and p=.002 belongs to the 9-month interaction; corrected 2026-09-04 after direct verification. Arm-level dropout and analyzed-N breakdowns reported earlier could not be re-verified against accessible text — treat as unverified. The PhD was co-funded by Oto Health and a co-author is affiliated with Oto Health. The larger DEFINE non-inferiority trial (N=198, vs therapist care) concluded Dec 2024 but remains unpublished.
Limitations and conflicts of interest
Unblinded, waitlist control, completer-only analysis, differential dropout.
Funding / conflicts: Company-linked (PhD co-funding; company CSO co-author).
Corrections to this record
- 2026-09-04: Primary-result correction: 6-mo between-group TFI 16 [6–25] p=.002 → 9 points [2, 16] p=.006; d=0.62 (6 mo) / d=0.54 (9 mo, p=.002).
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.