Sources and bibliography

The educational content of this site and the app draws on the literature listed here, and so does the technical design of the audio. Where a public link exists, it’s included. Citing a study is not a claim that Tonaleve reproduces its result: Tonaleve is a general wellness product and does not treat any condition.

Clinical guidelines and consensus statements

• Tunkel DE, et al. Clinical Practice Guideline: Tinnitus. American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS), 2014.
• NICE NG155 — Tinnitus: assessment and management. National Institute for Health and Care Excellence (UK), 2020.
• Cima RFF, et al. A multidisciplinary European guideline for tinnitus. HNO, 2019.

Characterizing tinnitus in the literature (tinnitus matching)

• Standard Clinical Method vs Tinnitus Likeness Rating — test–retest reliability comparison between matching methods (pitch 84% vs 23%; loudness 73% vs 40%). PubMed 30267085
• Agreement and Reliability of Tinnitus Loudness Matching and Pitch Likeness Rating — ICC ~0.73 (pitch) and ~0.48 (loudness) at two weeks. PLoS ONE 2014
• Repetitive Recursive Matching — repetition and recursion reduce octave confusion and improve test–retest reliability. Audiology & Neurotology, 2020. Karger
• McMillan GP, Cannon JB. A Bayesian Perspective on Tinnitus Pitch Matching. Ear & Hearing, 2014.
• Henry JA, et al. Comparison of manual and computer-automated procedures for tinnitus pitch matching. Journal of Rehabilitation Research & Development, 2001. VA RR&D
• iPod-Based Automated Tinnitus Pitch Matching. PubMed 25690779
• Watson AB, Pelli DG. QUEST: a Bayesian adaptive psychometric method. Perception & Psychophysics, 1983. · King-Smith PE, et al. (1994) — basis for Bayesian adaptive methods (ZEST).
• Casolani C, et al. High-frequency audiometry using Bayesian active learning. Frontiers in Artificial Intelligence, 2024. Frontiers
• ISO 226 — equal-loudness contours (level compensation across frequencies).
• Levitt H. Transformed up-down methods in psychoacoustics. JASA, 1971 — 2-down/1-up staircase procedure.

Questionnaires and outcome measures

• Meikle MB, et al. The Tinnitus Functional Index (TFI). Ear & Hearing, 2012 — clinically relevant change ≈ 13 points.
• Newman CW, et al. Tinnitus Handicap Inventory (THI). 1996.
• Zeman F, et al. — THI and clinical change threshold (~7 points). 2011.

Cognitive behavioral therapy and counseling

• Fuller T, et al. Cognitive behavioural therapy for tinnitus. Cochrane Database of Systematic Reviews, 2020 — mean improvement −10.9 THI points vs control.
• Scherer RW, Formby C (TRTT Study Group). Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life. JAMA Otolaryngology, 2019.

Sound and masking — general

• Sereda M, et al. Sound therapy (masking) in the management of tinnitus in adults. Cochrane Database of Systematic Reviews, 2018 — inconclusive evidence as a standalone treatment.
• Henry JA, et al. How to Manage Your Tinnitus: A Step-by-Step Workbook (3rd ed.) — Progressive Tinnitus Management (PTM) model, VA/NCRAR, 2022.
• Searchfield GD, Sanders PJ. A randomized single-blind controlled trial of a prototype digital polytherapeutic for tinnitus. Frontiers in Neurology, 2022.
• Searchfield GD, et al. — framework for four generations of digital sound therapy. Frontiers in Digital Health, 2021.

Notched sound

• Teismann H, et al. Tailor-made notched music training — effect only in tinnitus ≤ 8 kHz. PLoS ONE, 2011.
• Stein A, et al. — large RCT, negative primary outcome. BMC Neurology, 2016.
• Atipas S, et al. — RCT, negative primary outcome. 2021.
• Wunderlich R, et al. — optimal notch width of ½ octave. PLoS ONE, 2015.
• Meta-analyses: European Archives of Oto-Rhino-Laryngology, 2024; Jiang, 2025.

AM modulation and residual inhibition

• Neff P, et al. — amplitude-modulated tones and tinnitus suppression. 2017 and 2019.
• Amplitude-modulated sound enrichment. Hearing Research, 2025.
• Sendesen E. — residual inhibition as a predictor of response. 2024.

Acoustic and bimodal neuromodulation

• Tass PA, et al. Counteracting tinnitus by acoustic coordinated reset neuromodulation. Restorative Neurology and Neuroscience, 2012.
• RESET2 — replication trial, inconclusive. PMC5681957
• Wegger M, et al. — review of ACRN. 2017.
• Conlon B, et al. Bimodal neuromodulation combining sound and tongue stimulation. Science Translational Medicine, 2020. · TENT-A3. Nature Communications, 2024. · FDA De Novo authorization of the Lenire device, 2023.
• Marks KL, Shore SE, et al. Auditory-somatosensory bimodal stimulation. JAMA Network Open, 2023.

Interventions ruled out by the evidence

• Ginkgo biloba for tinnitus — Cochrane, 2022: no effect.
• Zinc — Cochrane, 2016: no effect.
• Betahistine — Cochrane, 2018: no effect.

Hearing safety

• WHO — Make Listening Safe initiative and the ITU-T H.870 standard: safe listening, 80 dBA / 40 hours per week, 3 dB exchange rate.
• NIOSH — Criteria for a Recommended Standard: Occupational Noise Exposure, 1998 (REL 85 dBA TWA-8h).

Digital and regulatory research for reference

• Automatic identification of tinnitus malingering. npj Digital Medicine, 2022. Nature
• Stoyanov SR, et al. Mobile App Rating Scale (MARS). JMIR mHealth and uHealth, 2015. · Sereda M, et al. — MARS evaluation of tinnitus apps. JMIR mHealth and uHealth, 2019.
• DEFINE trial (Oto app) — protocol: PLOS ONE, 2023 (e0292562); decentralized operations: PLOS ONE, 2025 (e0324927).
• SilentCloud — real-world data. Frontiers in Audiology & Otology, 2026.
• FDA — General Wellness: Policy for Low Risk Devices (guidance), 2019.
• Tinnitus — current developments (general review, 2024). PMC12634720

Transparency note: we cite the evidence including negative results and inconclusive reviews of the techniques we offer. If you find an incorrect or outdated citation, let us know and we’ll fix it.