Clinically tested.
Evidence based.

Oto is the guided tinnitus program built on science and compassion.
In partnership with

We build evidence step by step

Studies on Oto

Digital thErapy For Improved tiNnitus carE Study (DEFINE): A Randomised Controlled Trial

Smith ME, Sharma D, Rivero-Arias O, Rand K, Barrack L, Ogburn E, Young M, Field P, Multmeier J, Muzaffar J.

The Oto program was compared directly to one to one CBT in the largest trial of its kind.

Number of patients
210
Location
United Kingdom
Design
Randomized Controlled Trial
Status
Peer review

Digital solutions for tinnitus: A randomised controlled trial of the Oto digital therapeutic

Mui B, Muzaffar J, Chen J, Bidargaddi N, Shekhawat GS.

An earlier version of the Oto program was compared to a waiting list control.

Number of patients
96
Location
Australia
Design
Randomized Controlled Trial
Status
Published

Multimodality Smartphone App Delivered Therapy for Tinnitus:  A Prospective Pilot Study

Muzaffar J.

The prototype Oto program lowered tinnitus severity after three months.

Number of patients
53
Location
Multi-country
Design
Single arm pilot
Status
Complete

Studies on CBT

Cognitive behavioural therapy for tinnitus (Cochrane Review, 2020)

Fuller T, Cima R, Langguth B, Mazurek B, Vlaeyen JWS, Hoare DJ.

Systematic Review

Read more

Systematic Review and Network Meta-analysis of Cognitive and/or Behavioral Therapies (CBT) for Tinnitus (2020)

Landry EC, Romo Sandoval XC, Simeone CN, Tidball G, Lea J, Westerberg BD.

Systematic Review & Meta Analysis

Read more

A systematic review and meta-analysis of randomised controlled trials of CBT for tinnitus distress (2011)

Hesser H, Weise C, Zetterqvist Westin V, Andersson G.

Systematic Review & Meta Analysis

Read more

Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial (The Lancet, 2012)

Cima RFF, Maes IH, Joore MA, Scheyen DJWM, El Refaie A, Baguley DM, Anteunis LJC, van Breukelen GJP, Vlaeyen JWS.

Randomized Controlled Trial

Read more

Effectiveness of Internet-Based CBT vs Face-to-Face Clinical Care for Tinnitus: A Randomized Noninferiority Trial (JAMA Otolaryngology, 2018)

Beukes EW, Andersson G, Allen PM, Manchaiah V, Baguley DM.

Randomized Controlled Trial

Read more

Internet-Delivered Cognitive-Behavior Therapy for Tinnitus: A Randomized Controlled Trial (Psychosomatic Medicine, 2016)

Weise C, Kleinstäuber M, Hesser H, Westin VZ, Andersson G.

Randomized Controlled Trial

Read more

Internet-based guided self-help versus group CBT for chronic tinnitus: a randomised controlled trial (Psychotherapy & Psychosomatics, 2014)

Jasper K, Weise C, Conrad I, Andersson G, Hiller W, Kleinstäuber M.

Randomized Controlled Trial

Read more

Relieve your tinnitus in 10 minutes per day

A clinically-proven program that allows you to tune out the noise and live again.

Start today

FAQs

What studies on Oto have been completed so far?

Oto has been assessed in two randomised controlled trials and a pilot study. One RCT is published; the DEFINE trial is running with the University of Cambridge. See each study on this page for status and links.

What is the DEFINE trial and who ran it?

DEFINE is a head-to-head non-inferiority randomized controlled trial comparing Oto with clinician-delivered CBT for tinnitus. It was run by the University of Cambridge and partners; the protocol is published in PLOS ONE.

It's the largest tinnitus trial of its kind.

What does “non-inferiority” mean here?

It means the trial is designed to test whether Oto performs no worse than clinician-delivered CBT by a small, pre-set allowance. This is a rigorous way to compare to an established approach. The DEFINE protocol explains this design.

What outcomes does DEFINE measure?

The primary outcome is change in the Tinnitus Functional Index (TFI) at 26 weeks, with follow-ups to one year. Safety and health-economic measures are also collected.

Where can I read the DEFINE protocol?

You can read the peer-reviewed protocol on PubMed / PLOS ONE.

What are tinnitus clinical guidelines?

They are independent, evidence-based recommendations that help clinicians decide what to offer and when. Examples include NICE in the UK and AAO-HNSF in the US.

Do guidelines recommend CBT for tinnitus?

Yes. Major guidelines recommend the use of CBT for managing tinnitus-related distress, and note CBT can be delivered in different formats, including digital.

When will new results be added here?

We’ll update this page after peer-reviewed publications go live and share a plain-English summary with links to the journals.

Can I participate in Oto's research?

Please get in touch. We don't currently have any active opportunities, but can let you know if any arise.