The effectiveness of Lenire for tinnitus

Tinnitus is a condition that affects millions of people, often causing persistent ringing, buzzing, or hissing sounds that can disrupt daily life. Yet, more than three quarters of people suffering from tinnitus in the UK have never received any treatment for their condition.¹

If you’ve been searching for a solution for your tinnitus, you’ve likely heard of Lenire – a pioneering treatment gaining significant attention for its innovative approach.

So, does Lenire work for tinnitus? In this article, I’ll explore the clinical evidence, patient results, and how Lenire fits into the broader landscape of tinnitus treatments.

Lenire is a medical device designed to reduce the symptoms of tinnitus through bimodal neuromodulation. Bimodal neuromodulation combines two types of stimulation:

• Sound therapy, delivered via headphones.
• Gentle electrical stimulation, applied to the tongue using a custom-fit tongue tip.

This unique dual-action therapy aims to retrain the brain, promoting neuroplasticity – the brain’s ability to adapt and reorganise itself. Over time, this is thought to reduce the perception and severity of tinnitus, helping patients regain control of their lives.

Learn more about how the Lenire device works to relieve tinnitus.

^{Lenire uses sound therapy, delivered via headphones, and gentle electrical stimulation, applied to the tongue using a custom-fit tongue tip.}

The effectiveness of the bimodal neuromodulation provided by the Lenire device has been well researched in a number of large-scale clinical studies.

Research findings published in 2022 showed clear improvements in patients’ reported tinnitus symptoms, with 95% of the study’s treatment-compliant participants reporting a reduction in tinnitus symptoms following a 12-week treatment period. What’s more, 91% of these participants had continued improvement in tinnitus severity when evaluated 12-months after treatment was completed.²

Further, recent research published in 2024 has demonstrated that Lenire’s unique bimodal neuromodulation is more effective at providing relief from tinnitus than sound therapy alone, with 88.6% of participants responding that they would recommend Lenire as a tinnitus treatment.³

These latter findings were instrumental in Lenire securing FDA approval in March 2023, making Lenire the first bimodal neuromodulation device approved for tinnitus treatment in the U.S.

Although research has shown a reduction in tinnitus symptoms in most participants following a 12-week treatment period, the optimum treatment period can vary based on individual factors.

A typical Lenire treatment journey can last between 12 to 24 weeks, with patients using the device for 30 minutes twice daily. At Alto, our specialist will specify this as part of your tailored Lenire treatment plan, and at the end of your recommended treatment period, you will get advice about continued, independent use of your Lenire device from home.

For best results, we always advise that Lenire is used for the full treatment period, even if positive short-term results are achieved.

In addition to clinical trials, Lenire has been used in real-world settings with outcomes that mirror those seen in studies. A recent review of patient records in the U.S. suggests that:

• the majority of users reported meaningful reduction in their tinnitus symptoms,
• and patient satisfaction rates were consistently high, reinforcing Lenire’s effectiveness outside the clinical trial setting.⁴

So, how does Lenire fit into the broader landscape of tinnitus treatments?

Sound therapy has for some time been used to temporarily mask tinnitus. However, the research outlined above suggests that the unique bimodal neuromodulation (sound therapy plus gentle electrical stimulation) provided by Lenire is more effective at providing relief from tinnitus than sound therapy alone.³

For the many individuals who experience tinnitus in the context of hearing loss, hearing aids have been found to provide some relief from symptoms. By amplifying ambient sounds, the hearing aid is thought to make the tinnitus less noticeable. Preliminary data suggests that hearing aid users may experience additional benefit to their tinnitus symptoms by combining use of the Lenire tinnitus treatment device.⁵

This may also be true for cognitive behavioural therapy (CBT). CBT aims to help patients manage their emotional responses to tinnitus by changing their pattern of behaviour and/or thinking about their tinnitus, which, in turn, is thought to reduce distress and intrusiveness. Lenire may offer potential to complement CBT therapy when used in combination, however further research is needed to confirm this.

Despite the convincing evidence, it’s essential to approach Lenire with realistic expectations. Whilst the majority of patients studied experienced meaningful improvements, Lenire is not a cure for tinnitus.

Treatment results with Lenire can vary based on individual factors such as the duration and severity of tinnitus. Therefore, alternative or complementary tinnitus treatments might be recommended to find the right tinnitus solution for you.

For patients with tinnitus linked to hearing loss, combining Lenire with hearing aids may provide greater relief. Additionally, counselling or CBT may be recommended to address the emotional impact of tinnitus alongside a Lenire device treatment plan.

Overall, the evidence suggests that Lenire offers a promising option for many people experiencing tinnitus, backed by clinical trials, FDA approval, and positive real-world findings.

While it’s not a guaranteed solution for everyone, Lenire’s innovative approach and encouraging success rates make it a valuable addition to the tinnitus treatment landscape.

1. There is convincing evidence that Lenire is effective for most people, with 95% of compliant participants demonstrating an improvement of tinnitus severity after 12 weeks of treatment.
2. Lenire’s unique bimodal neuromodulation is clinically proven to be more effective at treating moderate or worse tinnitus than sound-only stimulation.
3. Everyone’s experience of tinnitus is different, so alternative or complementary tinnitus treatments might be recommended to find the right tinnitus solution for you.

Will Lenire work for you? Watch our Am I a Candidate For Lenire? video where senior audiologist, Adam Bostock explains who is a good candidate for Lenire, who might not be suitable, and the factors we carefully consider here at Alto.

If you’re considering Lenire, start by booking an assessment with one of our specialist audiologists. Our team will guide you through the process, ensuring you receive a treatment plan tailored to your needs.

1. Conlon B, Langguth B, Hamilton C. et al. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci. Transl. Med. 12, eabb2830 (2020).

2. Conlon B, Hamilton C, Meade E. et al. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Nature Scientific Reports (2022). 12, 10845 https://doi.org/10.1038/s41598-022-13875-x

3. Boedts M, B. A., Khoo G, et al. Combining sound with tongue stimulation for the treatment of tinnitus: a controlled pivotal trial. Nature communications (2024). https://www.nature.com/articles/s41467-024-50473-z

4. McMahan E, & Lim H. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review (2024). https://doi.org/10.1101/2024.08.22.24312175

5. McMahan E. Hearing Aid Users Received Additional Benefit in Their Tinnitus Journey with Lenire® Bimodal Neuromodulation Treatment.

Article by Adam Bostock