The Northwell Health Clinical Trial of AudioNotch
Randomized controlled trial · Northwell Health · Otology & Neurotology (2026)
Researchers at Northwell Health enrolled 65 tinnitus patients and randomly assigned them to receive AudioNotch or standard care, then followed them for 12 months. Patients given AudioNotch improved significantly more than those given standard care, and were far more likely to stick with sound therapy. This page explains what the study found, how it was run, and, just as importantly, what it does not show.
What the study found
The primary outcome was the Tinnitus Handicap Inventory (THI), a validated questionnaire measuring how much tinnitus interferes with daily life. Over the 12-month study, assignment to the AudioNotch group was associated with a significantly greater reduction in THI than assignment to standard care (linear regression: β −10.02, 95% CI −18.20 to −1.83, P=0.017). By 12 months, the AudioNotch group showed a mean THI change of −9.6 while the standard care group had worsened by +5.0.
Adherence also differed sharply. At the 6-week follow-up, 70% of patients given AudioNotch were still using sound therapy, versus 32% of the standard care group (P=0.020), 2.2 times higher. Patients given AudioNotch were also more likely to stay in the study at every follow-up visit: by 12 months, 93.8% of the standard care group had been lost to follow-up, versus 69.7% of the AudioNotch group.
Data table
| Visit | AudioNotch | Standard care | Precision |
|---|---|---|---|
| 6 weeks | −7.8 | −0.1 | approximate (Figure 2) |
| 3 months | −11.2 | −4.4 | approximate (Figure 2) |
| 6 months | −17.8 | −2.0 | approximate (Figure 2) |
| 12 Monate. | −9.6 | +5.0 | exact (paper text) |
How the study was run
The trial ran from September 2019 to May 2023 at Northwell Health's Department of Otolaryngology neurotology practice, with approval from the Northwell Health Institutional Review Board (IRB 25-0171). Adults with subjective tinnitus were randomized using institutional randomization software: the treatment group received a free subscription to AudioNotch, while the standard of care group could use notched sound therapy but had to pay for it themselves. Both groups completed the THI and reported their sound therapy use at 6 weeks, 3 months, 6 months, and 12 months.
A preliminary analysis of the same trial was published in 2023, covering results through 3 months; at that early point there was no significant between-group difference in THI change. The 2026 updated analysis, covering the expanded group and the full 12 months of follow-up, is the definitive report and the source for every number on this page.
What the study does not show
Improvement was not tied to hours of listening. Reported use of notched sound therapy was not associated with THI change (β 1.50, 95% CI −6.89 to 9.88, P=0.72). In other words, this trial shows that being given AudioNotch helped, but it does not show that the notch mechanism itself caused the improvement. The authors attribute the benefit to removing the cost barrier plus psychological factors: empowerment, perceived support, and accountability.
Other limitations the authors report: attrition was high at later visits (especially in the standard care group), few patients met the prescribed 2 hours per day of listening, use was self-reported, and the final sample (33 and 32 per group) fell just short of the 38 per group the power analysis called for.
We think the honest reading is this: a randomized trial found that patients given AudioNotch did meaningfully better than patients who were not, over a full year, and engagement with structured therapy appears to matter alongside the sound itself. That is a real, useful result. It is not proof that notched sound therapy cures tinnitus, and nobody should sell it as one.
The wider evidence on notched sound therapy
The Northwell trial tested AudioNotch as a product. A separate body of research has tested the notched sound approach itself, with mixed results:
- Okamoto et al. (2010, PNAS) and Teismann et al. (2011, PLOS ONE) found reductions in tinnitus loudness and tinnitus-related brain activity after tailor-made notched music training.
- Lugli et al. (2009) reported reductions in perceived tinnitus volume with notched ("windowed") white noise.
- Stein et al. (2016, BMC Neurology), a 100-participant randomized trial of notched music, found no significant effect on its primary outcomes.
- Tong et al. (2023, Ear and Hearing), a 120-participant randomized trial, found tailor-made notched music training effective for chronic tinnitus, with simpler processes and better compliance than tinnitus retraining therapy.
- Meta-analyses disagree with each other, and overall reviews of sound therapy for tinnitus rate the evidence as low certainty. Results vary from person to person, and some people notice no benefit.
That mixed picture is exactly why AudioNotch comes with an unconditional 30-day money-back guarantee, and why we do not promise a particular outcome.
The citation
doi:10.1097/MAO.0000000000004730 · PubMed · Author copy (ResearchGate)
Preliminary analysis: Adamovich-Zeitlin R, et al. Otology & Neurotology, 2023. PubMed 36624601.
Independence and disclosure: this study was designed, run, analyzed, and published by Northwell Health researchers. AudioNotch provided free study subscriptions for the treatment group and had no role in the design, analysis, or publication. Northwell Health and the authors do not endorse AudioNotch. The information on this page is not medical advice; if you have tinnitus, speak to a doctor first.