Name of treatment

Levo® Therapy System

Type of treatment

Sound therapy

Claims for treatment

Encourages habituation, reduces perceptual loudness and annoyance[1].

How treatment is delivered

Personalised therapy sound delivered via iPhone and earbuds whilst patient is asleep. Used for 90 days initially.

Potential negative consequences

Sound therapy is generally regarded as safe

Evidence offered:

Papers available

4

Conclusions drawn

Using the device shows a greater reduction in tinnitus loudness and greater reduction in TFI (Tinnitus Functional Index) scores than other forms of sound therapy[2]

Quality of evidence[3]

B

Does the BTA recommend this treatment?

No, until more high quality evidence is available

BTA opinion on this treatment:

Little independent evidence of effectiveness of Levo ® Therapy System (one study).

Would the BTA support further studies into this treatment?

Yes, provided study is of high quality and fully independent

Verdict: Safety - is this treatment harmful?

  Generally regarded as safe

Verdict: Efficacy - does this treatment work?

  Limited evidence that it is effective

[1] Treating your tinnitus while you sleep: the new Levo® Therapy System for tinnitus. The Tinnitus Clinic. https://www.thetinnitusclinic.co.uk/tinnitus-treatment/tinnitus-sound-stimulation-during-sleep [accessed 28 June 2019]

[2] Theodoroff SM, McMillanGP, Zaugg TL, Cheslock M, Roberts C, Henry JA. Randomized Controlled Trial of a Novel Device for Tinnitus Sound Therapy During Sleep American Journal of Audiology 2017;26 (4):543-554 doi: 10.1044/2017_AJA-17-0022

[3] A = Systematic review/meta analysis. B = Randomised control studies. C = Cohort studies. D = Case control studies. E = case studies/reports. +/- to be used to indicate quality within bands

Download this information:

Tinnitus_and_Levo_Therapy_System_June_2019.pdf

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Updated 28 June 2019