Oto

Unless noted, features apply to iPhone, iPad, and Android.

1. Adults 18+ only; a licensed hearing healthcare provider must confirm chronic tinnitus and prescribe Oto (clinician_enrollment). 'other' = clinical exclusions listed in the IFU (e.g. Meniere's disease, pulsatile or one-sided tinnitus, sudden hearing loss in last 90 days).
2. The current instructions describe a prescription, provider-guided program for adults with chronic tinnitus; use the applicable regional instructions.
3. A connection is needed to download the app, sign in, and download sessions and sounds; the IFU does not say whether already-downloaded content plays offline.
4. Account, TFI and journal data are stored in Oto's Firebase/Firestore backend; support messages, error logs and analytics events go to named third parties (Intercom, Sentry, PostHog). No user audio is recorded. Evidence: 8. Data Security.
5. These processors receive text and usage data (email, name, user ID, support messages, usage events, error logs), not audio. Evidence: 5. Third-Party Service Providers.
6. Applies to TFI questionnaire responses and journal entries, which Oto stores on its servers; TFI scores and usage are shared with the provider only if the user consents. Evidence: 1.1 Information You Provide Directly; 13.3 Protected Health Information.
7. By email request to support, not an in-app export. Evidence: 9.5 Portability.
8. Flinders University RCT, 96 Australian adults with chronic tinnitus, wait-list control, 9-month follow-up; intervention arm received an Oto subscription (pre-provider-model version). Partly funded by Oto Health Ltd; an Oto co-founder is a co-author. A second RCT (Cambridge DEFINE, 210 participants) has results in peer review.
9. Unblinded RCT vs wait-list (n=96, Australia), published 2025; mean TFI decrease 9 points vs control at 6 months. Studied an earlier subscription-era app version, not specifically v6.x.
10. DEFINE trial protocol (UK, open-label non-inferiority RCT of the Oto app vs one-to-one therapist-led tinnitus therapy; ISRCTN99577932). Several authors have financial interests in Oto Health Ltd.
11. Sound therapy plays through earphones, headphones or the phone speaker (headphones recommended). Not live captioning; audio sessions show on-screen words as they are spoken.
12. No special hardware; earphones/headphones optional (phone speaker works), headphones recommended. Minimum OS: iOS 17.0; Android 8.0.
13. Requires full access via a participating provider's prescription (new accounts cannot use the sound library before then). The IFU itself describes a 'Layered' sound category rather than a mixer.
14. Human coaching is delivered by the participating clinic's audiologist (one-to-one sessions in the care plan, outside the app); the provider can also recommend sessions and set Sound EQ in the app.
15. Only for users enrolled in one of Oto's live group programs; sessions run in Zoom and are not part of the core Oto program.
16. Requires a participating provider: the provider prescribes, advises sound use, can set Sound EQ and mark recommended Explore sessions; the core Program is a fixed six-module sequence.
17. Requires full access through a participating provider; the sleep timer also requires a prescription.
18. Requires a participating provider's prescription for full access. Human coaching is delivered by the clinic, not in the app, so it is not listed here.