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If you’ve been researching tinnitus treatments, you’ve probably heard of Lenire by now. Over the past year or so, I’ve been sharing my thoughts on the studies coming out about Lenire—discussing both the positives and the potential drawbacks with everyone following along on my YouTube channel. As an audiologist, I can tell you the evidence for this new treatment is increasingly compelling, and real-world data is now backing it up in a big way.

Why Lenire Stands Out

What makes Lenire so unique is that it’s the world’s first approved tinnitus treatment leveraging a technique called bimodal neuromodulation. Essentially, it pairs sound therapy with gentle energy stimulation of the tongue. Yes, the tongue may not be the first thing you think of when it comes to treating tinnitus, but it’s actually packed with sensory receptors that connect straight to the brain.

By using a small mouthpiece (the “tongue tip”) to deliver those mild impulses, in combination with synchronized sound therapy through Bluetooth headphones, Lenire aims to retrain the brain’s response to tinnitus. Traditional masking therapies just work to cover up the sound, but Lenire seeks to address the underlying neural activity that causes the perception of tinnitus.

A patient uses the Lenire device. Source: Neuromod Devices
A patient uses the Lenire device. Source: Neuromod Devices

A Quick Recap of Tinnitus Basics

Before diving into the study, let me just say I understand how frustrating tinnitus can be. Personally, I’ve had a high-pitched tone in both ears for as long as I can remember. Most days, it’s not an issue, but if I’m tired or stressed, that ringing can really ramp up.

If you’re dealing with tinnitus, you know that it can sound different for everyone—ringing, buzzing, whooshing, or maybe something else altogether. It can also fluctuate based on stress, sleep, or even illnesses. This variability is one of the reasons it’s so difficult to treat.

The New Real-World Study

So, what’s new? Recently, the Alaska Hearing and Tinnitus Center—one of the first US clinics to offer Lenire—shared the results of a real-world retrospective study. They monitored 220 patients who went through the Lenire treatment program, and they examined how effective it was in day-to-day life, outside of tightly controlled clinical trials.

Here’s the standout number: 91.5% of participants showed a clinically significant improvement in their tinnitus, measured by the Tinnitus Handicap Inventory (THI). For context, the THI is a standard tool in audiology for gauging how tinnitus impacts daily life—emotionally, functionally, and psychologically. A 91.5% responder rate is nothing to scoff at.

Source: Neuromod Devices
Source: Neuromod Devices

Speed and Magnitude of Improvement

Among those 220 Lenire users, 78% experienced significant improvement just halfway through the 12-week program (that’s after about 6 weeks of therapy). These findings line up well with previous Lenire studies, which also reported a positive correlation between improvements on the THI and real-life benefits.

But remember: tinnitus is highly individual. While the high responder rate is encouraging, there’s always going to be a subset of patients for whom any single treatment doesn’t work perfectly. That’s just the nature of medical care.

Hybrid Approach to Treatment

One aspect that intrigued me is the hybrid approach used in this study. The initial Lenire fitting was done in person, ensuring everyone was set up correctly and understood the technology. After that, follow-up appointments happened virtually, via telehealth. According to the study, patient outcomes were just as good under this hybrid model as they are in more traditional, in-person setups.

From an audiologist’s perspective, this is great news, because it means more people—especially those who live far from specialized clinics—could potentially access Lenire. It’s a promising shift toward making advanced treatments more broadly available.

Longer-Lasting Effects

If you’re looking into Lenire, another big question is how long the benefits stick around. Other research suggests that the positive effects of bimodal neuromodulation can persist for months or even years, as long as you stay consistent and follow any recommended protocols for maintenance.

Because it’s designed to promote healthier neural pathways in the brain, Lenire’s effects are not meant to be a quick, temporary bandage. Instead, the goal is to reshape the way your brain perceives the tinnitus signal.

What About Side Effects?

According to the study from Alaska Hearing and Tinnitus Center, there were no serious or major device-related adverse events. Only four patients (out of 220) saw an increase in their THI scores at the 12-week point. Three of them eventually returned to baseline through a combination of CBT, breathing exercises, and habituation. The fourth individual was dealing with a significant personal health crisis, which likely factored into their worsened tinnitus.

From a clinical standpoint, knowing that stress or traumatic events can intensify tinnitus is crucial. Even if a treatment like Lenire is beneficial for most, life circumstances sometimes overshadow or complicate progress.

Is This the Tinnitus “Cure”?

Let’s address the elephant in the room: Does Lenire cure tinnitus? The short answer is no. Like many tinnitus treatments, Lenire is not a one-size-fits-all magic bullet. Even so, the high number of people finding relief is impressive and represents a breakthrough in how we manage tinnitus.

If you’re just starting your journey with tinnitus, I recommend working with a qualified healthcare professional or audiologist who can provide a tailored plan. This might include Lenire, hearing aids, cognitive behavioral therapy, counseling, or other sound therapy options.

Looking Ahead

Ultimately, I find this real-world study to be incredibly encouraging. It’s one thing for a treatment to show promise in a tightly controlled clinical trial—it’s another for it to deliver strong results in real-world settings, across a diverse patient population.

If you’re dealing with tinnitus, don’t lose hope. There are multiple strategies to help reduce its impact, including stress management, good sleep hygiene, and regular hearing check-ups. And now, with accumulating evidence and flexible telehealth options, Lenire might be worth a closer look if you want a more comprehensive approach to managing your tinnitus.

References

  1. McMahan, E.E. and Lim, H.H., 2024. Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review. medRxiv., pp.2024-08; doi: https://doi.org/10.1101/2024.08.22.24312175