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Low-Level Laser Therapy for Tinnitus: Ten Randomised Trials, Eight of Them Negative

Four systematic reviews have examined laser therapy for tinnitus and reached four different conclusions. The reason they disagree is more useful than any of the verdicts, and it comes down to what each one was willing to count.

By Tinnitus Clarified TeamUpdated 6 min read

Key takeaways

  • A 2022 systematic review found ten randomised trials of laser therapy for chronic tinnitus, and eight of them reported it ineffective.
  • Reviews that also counted non-randomised studies read more warmly, which is the pattern expected when weaker designs are included rather than a sign that the treatment works.
  • The studies used ten different wavelengths and sessions from nine seconds to thirty minutes, so no clinic's protocol can claim the literature's support.
  • Even the positive 2013 trial reported a non-response rate of 57% straight after treatment. The 2024 VA/DoD guideline suggests against laser therapy for tinnitus.
  • Every review reports it as safe and well tolerated; the case against it is cost and expectation, not risk.

Evidence at a glance

Our evidence rating: F, Evidence against
Tinnitus Clarified Evidence RatingF — Evidence against

Available evidence suggests no benefit, or that potential harms outweigh benefits.

What it does not mean: That it is dangerous in every case. Read the specific evidence rather than treating the grade as a verdict.

How we rate evidence

Studied for:
Loudness
Distress
What the grade rests on
A 2022 systematic review of ten randomised trials, eight of which found it ineffective for chronic tinnitus; reviews that also counted non-randomised studies read more warmly

The honest caveat

The warmer reviews got there by counting weaker designs. The studies used ten different wavelengths and sessions from nine seconds to thirty minutes, so no clinic's protocol can claim the literature's support, and even the positive 2013 trial reported a non-response rate of 57% straight after treatment. It is not dangerous; the case against it is cost and expectation.

Where the guidelines land

Shown beside our grade, not folded into it: a guideline records what a professional body decided to do about the evidence, and the two can differ.

  • AAO-HNS 2014

    Not covered by this guideline

    No recommendation in it is about this treatment, which is not a verdict either way.

  • VA/DoD 2024

    Suggested against (weak)

    Suggests against low-level laser therapy for tinnitus management (weak against).

See it beside the other 29 graded treatments

The randomised evidence says low-level laser therapy does not work for chronic tinnitus: a 2022 review found ten randomised trials, and eight reported it ineffective. Reviews that counted weaker studies reached warmer conclusions.

Low-level laser therapy — usually called photobiomodulation in the research literature — is one of the more heavily marketed tinnitus treatments. Four systematic reviews have looked at it and reached four different conclusions.

That disagreement is the most useful thing on this page, because the reason for it is visible.

Start with the randomised trials only

A 2022 systematic review in European Annals of Otorhinolaryngology, Head and Neck Diseases asked a deliberately narrow question: what do the randomised controlled trials show? It found ten of them — two single-blind, eight double-blind.

Eight of the ten reported that photobiomodulation was ineffective for chronic tinnitus. One reported benefit lasting up to three months. One reported resolution figures of 30% with a diode laser and 100% with a Neodymium-doped Yttrium Aluminium Garnet laser — a result so far outside what the rest of the field produces that it belongs in the patterns that make a weak result look strong rather than in a summary of what laser therapy achieves.

The review also graded the trials: risk of bias was high in four, medium in five, and low in one. Its conclusion is that the effectiveness of photobiomodulation remains debatable and that properly powered trials with long-term follow-up are still needed.

Then widen the net, and the answer changes

A 2023 systematic review in The Journal of Laryngology and Otology searched more broadly and found 28 studies reporting outcomes in 1,483 people, plus two animal studies. Its conclusion: outcomes are "generally positive and superior to no photobiomodulation therapy", while evidence of long-term benefit is deficient.

Two reviews of the same treatment, two opposite headlines. The difference is what each counted — one admitted only randomised trials, the other admitted the wider literature. It is a recurring pattern: uncontrolled studies show a bigger effect than controlled ones, reliably enough that the gap between them is a measurement of bias rather than of treatment.

A 2021 review in the Journal of Speech, Language, and Hearing Research sits in between. It found seven randomised trials, judged one at low risk of bias and six at moderate, and reported that all seven found significant results of some degree — but with no consensus among them, and it declined to make any recommendation about clinical use.

The most recent, a 2025 review in Cureus covering nine clinical studies, reports short-term reductions in tinnitus severity with several studies beating placebo, and adds the durability caveat directly: those benefits often diminished after three to six months.

"Low-level laser therapy" is not one treatment

The 2023 review recorded the parameters the 28 studies used. They span ten different wavelengths, with sessions running from nine seconds to thirty minutes, and follow-up from seven days to six months.

That range is worth pausing on. A drug trial comparing doses that differed by a factor of two hundred would not be pooled into one verdict, and nobody would expect a single answer from it. When reviews of laser therapy disagree, part of the explanation is that they are not reviewing the same intervention — and part of why no clinic's protocol can claim the support of "the research on laser therapy" is that the research has not converged on a protocol.

The trial this page used to rest on

For a long time this article described a single study as the strongest available evidence, and it is worth keeping because it shows how a positive trial can still be a discouraging one.

A double-blind randomised trial examined laser therapy in patients whose tinnitus accompanied noise-induced hearing loss — all male workers aged 30 to 51, average tinnitus duration about two years — across 20 sessions delivered every other day, 20 minutes each. Against placebo it improved all three outcomes: a visual analogue scale, the Tinnitus Handicap Inventory, and tinnitus loudness.

Then the details. The non-response rate was 57% immediately after treatment and 70% at three months, and the authors describe the effect as fading after three months, calling the pattern "U-shaped" over follow-up.

So the positive trial reports that most participants did not meaningfully improve, and that those who did largely stopped having improved. Set beside eight randomised trials finding nothing, it reads less like the strongest evidence for laser therapy than like the high-water mark of it.

A newer device, a smaller trial

A 2025 randomised, single-blind, placebo-controlled trial in Clinical Otolaryngology tested a specific device, the TINI laser, in 38 participants across three arms: eight active treatments, four active followed by four sham, or sham only.

It found significant improvement in the emotional subscale of the Tinnitus Handicap Inventory and in loudness and perception scores in the fully active arm. The partly active arm improved during active treatment and those effects diminished once the sham sessions began. Its authors conclude that intermittent photobiomodulation may be effective and that long-term efficacy and safety still need exploring.

Thirty-eight participants, single-blind, one device. It is a reason to run a larger trial, not a reason to buy a course of treatment.

What to do with this

It is not dangerous. Every review reports laser therapy as safe and well tolerated, and none raises a safety signal. The argument against it is about money and expectation, not risk.

The randomised evidence does not support it. Eight of ten randomised trials found nothing; the reviews that read more warmly did so by counting weaker designs, and the one that stayed strict declined to recommend it.

If it is offered to you, the useful questions are what wavelength and session length the clinic uses, what evidence exists for that protocol specifically, and what the total cost of a course is. Given the parameter range in the literature, a clinic pointing at "studies on laser therapy" is usually pointing at studies of something other than what it is selling.

Where the guideline lands

The 2024 VA/DoD tinnitus guideline suggests against low-level laser therapy for tinnitus management (weak against). It is one of the few treatments that guideline comes out against rather than calling the evidence insufficient, and it reaches the same place as the randomised trials above.

How it compares

Compared with what the evidence can say about CBT or hearing aids where hearing loss is present, laser therapy is not a close call. How this site rates evidence sets out the standard being applied.

A note on what this page used to say

An earlier version of this article rested on that single 2013 trial and concluded it showed "a real effect rather than a placebo response". That was a fair reading of one trial and a poor description of the literature, which contains ten randomised trials, eight of them negative. The corrections log records the change.

Frequently asked questions

Does low-level laser therapy work for tinnitus?

The randomised evidence mostly says no. A 2022 systematic review restricted to randomised controlled trials found ten of them, and eight reported that photobiomodulation was ineffective for chronic tinnitus. One reported benefit lasting up to three months. Reviews that also counted non-randomised studies reached warmer conclusions, which is the pattern you would expect when weaker designs are included rather than a sign that the treatment works.

Why do different reviews of laser therapy disagree?

Mainly because of what each was willing to count, and partly because there is no single treatment to review. A 2023 review found 28 studies covering 1,483 people and called the outcomes generally positive; it included designs beyond randomised trials. A 2022 review that admitted only randomised trials found eight of ten negative. Those same 28 studies used ten different wavelengths and sessions ranging from nine seconds to thirty minutes, so 'low-level laser therapy' names a family of quite different procedures rather than one thing that either works or does not.

What did the positive laser therapy trial show?

A double-blind randomised trial in male workers aged 30 to 51 with noise-induced hearing loss, given 20 sessions over about six weeks, found improvement on all three measures against placebo. Read the rest of the paper and the result narrows: the non-response rate was 57% immediately after treatment and 70% by three months, and the authors describe the effect as fading after three months. So even the positive trial reports that most participants did not meaningfully improve.

Is laser therapy for tinnitus safe?

The reviews consistently report it as safe and well tolerated, and none of them raises a safety concern. That matters for how to weigh it: the argument against laser therapy is not that it is dangerous but that the randomised evidence does not support paying for it, and courses are typically sold as a block of appointments.

What is the theory behind laser therapy for tinnitus?

A low-intensity laser is directed at or near the ear, on the theory that it improves cochlear microcirculation and cellular metabolism — blood flow and cell function in the inner ear. The premise is plausible and shares ground with other blood-flow theories of tinnitus, such as the one behind ginkgo. A plausible mechanism is a reason to run trials, not a substitute for what they found.

Sources

8 named sources

Show the list
  1. Talluri, Palaparthi et al., 2022Systematic review

    Efficacy of photobiomodulation in the management of tinnitus: A systematic review of randomized control trials, European Annals of Otorhinolaryngology, Head and Neck Diseases, PubMed (opens in a new tab)
  2. Ferreira, de Matos et al., 2021Systematic review

    Effects of Low-Level Laser Therapy as a Therapeutic Strategy for Patients With Tinnitus: A Systematic Review, Journal of Speech, Language, and Hearing Research, PubMed (opens in a new tab)
  3. Nikookam, Zia et al., 2023Systematic review

    The effect of photobiomodulation on tinnitus: a systematic review, The Journal of Laryngology and Otology, PubMed (opens in a new tab)
  4. Abdali, Almutairi et al., 2025Systematic review

    Low-Level Laser Therapy and Photobiomodulation for Tinnitus and Sudden Sensorineural Hearing Loss: A Systematic Review, Cureus, PubMed (opens in a new tab)
  5. Choi, Lee & Jung, 2025Clinical trial

    Evaluation of the Photobiomodulation Treatment With the TINI Laser Device for Managing Chronic High-Frequency Tinnitus: A Randomised Controlled Trial, Clinical Otolaryngology, PubMed (opens in a new tab)
  6. Mollasadeghi, Mirmohammadi et al., 2013Clinical trial

    Efficacy of low-level laser therapy in the management of tinnitus due to noise-induced hearing loss: a double-blind randomized clinical trial, TheScientificWorldJournal, PMC (opens in a new tab)
  7. VA/DoD Clinical Practice Guideline for the Management of Tinnitus (2024)Clinical guideline

    Provider Summary, Department of Veterans Affairs (opens in a new tab)
  8. NIDCDHealth authority

    Tinnitus Fact Sheet (NIH) (opens in a new tab)

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