What side effects are associated with this type of intervention?

Treatments for tinnitus similar to the OtoBand, such as neurostimulation devices, generally have mild side effects. These can include sensations like warmth, tingling, or numbness in the area of application. Other potential side effects may include muscle spasms, pain, or discomfort in the treated area. Serious adverse events are rare. For broader tinnitus treatments, side effects can vary widely depending on the method used, ranging from mild discomfort to more significant issues like dizziness or visual disturbances.

What prior FDA approvals exist?

There are currently no FDA-approved drugs specifically for the treatment of tinnitus. However, various devices have been explored for their potential benefits in managing tinnitus symptoms. The OtoBand, which is being studied for its ability to reduce the perceived loudness of tinnitus, represents a novel approach in this area. Similar non-pharmacological treatments, such as sound therapy devices and hearing aids, have been used to manage tinnitus by masking the tinnitus sound or improving hearing, but these are not specifically FDA-approved for tinnitus treatment.

What other types of research exist?

Promising novel alternatives to the OtoBand for tinnitus treatment in 2024 include: 1) Neuromodulation devices such as Lenire, which uses bimodal neuromodulation combining sound and tongue stimulation. 2) Pharmacological treatments like the use of NMDA receptor antagonists and potassium channel modulators, which are currently under investigation. 3) Cognitive Behavioral Therapy (CBT) delivered via digital platforms, which has shown effectiveness in managing tinnitus symptoms. 4) Hearing aids with integrated tinnitus masking features, which can help reduce the perception of tinnitus.

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Behavioural Intervention

OtoBand for Tinnitus

N/A

Waitlist Available

Led By Didier Depireux, PhD

Research Sponsored by Otolith Labs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female subjects age 18 to 70 years old

Tinnitus that is constant or predictable

Must not have

Taking benzodiazepines (e.g. clonazepam, lorazepam, diazepam)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up device use log over two week period of use by the study participant

Summary

This trial tests if the OtoBand, a wearable device, can reduce the loudness of tinnitus. It targets people with tinnitus and compares the effects of a real device to a non-active version. Participants will report any changes in their tinnitus loudness.

Who is the study for?

This trial is for people aged 18-70 with tinnitus lasting at least 90 days and a significant impact on their life, as measured by a specific questionnaire. Participants need internet access, an online payment account, and no recent skull surgery or implants. Those taking certain medications like benzodiazepines or with recent eye issues are excluded.

What is being tested?

The study tests the OtoBand's effectiveness in reducing tinnitus loudness compared to a placebo. Participants will use both the real device and placebo at different times over about 30 days, not knowing which they're using when to ensure unbiased results.

What are the potential side effects?

Since this trial involves a non-invasive device (OtoBand), side effects may be minimal but could include discomfort from wearing the device or potential psychological effects if participants perceive changes in their condition.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 70 years old.

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I always have ringing in my ears or it happens in a pattern I can predict.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking benzodiazepines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ forms filled out daily over two week period by the study participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~forms filled out daily over two week period by the study participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and forms filled out daily over two week period by the study participant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in bothersomeness of Tinnitus as measured by Tinnitus Handicap Questionnaire

Secondary study objectives

Change in Quality of Life Measures as measured by the Tinnitus Handicap Questionnaire

Identification of a preferred power level for tinnitus as determined by Otoband device log.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Otoband efficacy on TinnitusActive Control1 Intervention

Participants will wear the Otoband on the flat part of the right mastoid bone, about an inch behind the pinna and level with the ear canal. Each participant will select his/her preferred stimulation level. The OtoBand will be programmed to operate at one of three power levels that are thought to be effective. The OtoBand will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form.

Group II: Placebo device efficacy on TinnitusPlacebo Group1 Intervention

The placebo device will use the same case, headband and battery as the OtoBand. The transducer in the OtoBand will be rotated 90 degrees, so that the placebo device will vibrate in a direction ineffectual at providing bone conducted vibrations. The vibrations will be in the horizontal plane, parallel to the skull, and will not have their energy penetrating the skull all the way to the vestibular system. Each participant will select his/her preferred stimulation level. The placebo devices will be made to vibrate at one of three power levels, none of which are thought to be effective. The placebo will record what power level is selected and how long it was operating at that power level as well as the date and time a usage started. The "use log" will be downloaded at Otolith's lab once the device is received. The participant will wear the device for 30 minutes and record their Tinnitus level in a Google Form.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tinnitus include sound therapy, cognitive behavioral therapy (CBT), and the use of devices like hearing aids or sound-masking devices. Sound therapy works by providing external noise to mask the internal sounds of tinnitus, thereby reducing its perceived loudness. CBT helps patients manage the emotional and psychological impact of tinnitus. Devices like the OtoBand aim to reduce the perceived loudness of tinnitus through neuromodulation, which alters nerve activity in the auditory pathways. Understanding these mechanisms is crucial for patients as it helps them choose the most effective treatment tailored to their specific symptoms and improves their quality of life.