Name of treatment

Antinitus® Relief Patch Tinnitus Treatment

Type of treatment

Physical intervention

Claims for treatment

Reduces discomfort from tinnitus.[1] 

“[the patch] contains a unique microscopic raster, which, with the help of incident visible and thermal light, creates a regular and organised fractal light. In contact with fractal light, water molecules in biological tissues adopt a more coherent state.

The hypothesis is that an elevated reorganisation of water in the biological environment may modulate the chaotic audio loops in the auditory system that represent the various conscious sound experiences that we call tinnitus and hence provide relief.”[2]

How treatment is delivered

A patch is applied behind the ear in which tinnitus is experienced. The patch is replaced every day for three weeks.

Potential negative consequences

Skin irritation; cost

Evidence offered:

Papers available

Two[3]

Conclusions drawn

Pilot study showed increase in tinnitus severity in 50% of patients, and no significant changes in tinnitus annoyance, quality of life and sleep initiation time.[4]

Larger study showed there was no statistically significant difference in tinnitus annoyance, Tinnitus Handicap Inventory or well-being between the active (biomodulator) and placebo groups directly at the end of treatment.[5]

Quality of evidence[6]

B/C

Does the BTA recommend this treatment?

No

BTA opinion on this treatment:

There is evidence that this treatment does not work. There is no plausible mechanism for this treatment to work.

Would the BTA support further studies into this treatment?

No

Verdict: Safety - is this treatment harmful?

  Limited potential for harm

Verdict: Efficacy - does this treatment work?

  Evidence of no effect

Comments

Läkemedelsverk (the Swedish Medical Products Agency) banned Antinitus® from sale in October 2018 as there was no evidence of its effectiveness[7]. An appeal from the manufacturer in December 2019 was unsuccessful, meaning that the product can no longer be sold within the European Union. However, it is still on sale in many other parts of the world[8].

Date completed

March 2022

Date for revision

March 2025

 

We welcome feedback on all our information. Please send any corrections or updates for consideration to Nic Wray, Communications Manager on [email protected]

 Download this information:

antinitus relief patch.pdf

[1] https://www.antinitus.com/how-antinitus-works/ [accessed 23 October 2020]

[2] https://www.antinitus.com/product/antinitus-tinnitus-relief-patch-treatment/ [accessed 23 October 2020]

[3] Although the Antinitus website claims three, the links for two go to the same paper.

[4] Ahnblad, P. Pilot Investigation of a Topographical Filter Dermal Patch in Patients with Tinnitus. International Tinnitus Journal. 2017. 21 (1): 7-13

[5] Ahnblad P, Nordkvist A. A Randomized, Placebo-Controlled, Double-Blind, Parallel Groups Study Evaluating the Performance and Safety of a Steady State Coherent Biomodulator Patch in the Treatment of Subjective Tinnitus. International Tinnitus Journal.. 2017; 21(2): 157-167

[6] 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

[7] Hake, C-M. Domstol ger Läkemedelsverket rätt om tinnitusplåster in Dagens Medicin, 20 January 2020 (in Swedish). Available from https://www.dagensmedicin.se/specialistomraden/medicinsk-teknik/domstol-ger-lakemedelsverket-ratt-om-tinnitusplaster/ [Accessed 4 January 2022, translated via Google Translate]

[8] Hörselskadades Riksförbund. Kritiserat tinnitusplåster förbjuds av Läkemedelsverket. 29 October 2018 (in Swedish). Available from https://hrf.se/kritiserade-tinnitusplastret-forbjuds-av-lal/ [Accessed 4 January 2022, translated via Google Translate]

Updated 9 March 2022

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