Lenire® was launched as a neuromodulation based Tinnitus treatment device in late 2019. Neuromodulation is a technology driven treatment that allows a medical device to directly impact the activity of specific nerves, altering or modulating signals. It can’t cure you of Tinnitus, but can help you manage its severity, thereby potentially helping you improve your quality of life. Ever since its launch as a breakthrough Tinnitus treatment, it has been gaining steady popularity. But, is the Lenire Tinnitus treatment something you can consider to help you with the ringing in your ears? What are its pros and cons? Let’s explore.
Advantages of Lenire Tinnitus Treatment
Results backed by clinical trials
This is the first neuromodulation based Tinnitus treatment that has been backed*1 by clinical trials involving as many as 500 subjects. Access the study here.
What is Your Tinnitus Handicap Score?
Calculate your THI Score in about 2-3 Minutes
The clinical trials presented the following encouraging results
- 80.1%*2 of participants reported an improvement to their THI (Tinnitus Handicap Inventory) Score
- Average THI reduced from 43.7 to 31.1
- 80% of participants who reported an improvement in their Tinnitus symptoms managed to maintain said improvement 12 months after stopping treatment, suggesting strong sustainability of results
*1 The Clinical Study was not independent. It was sponsored by the device’s manufacturer – Neuromod, a company based out of Dublin, Ireland
*2 The study counted any improvement as a success. It did not provide additional data on the breakup suggesting significant and insignificant improvement
Personalized for every Tinnitus Patient
Neuromodulation is an approach where a neurological pathway response is altered to try to provide relief from a certain debilitating symptom such as Tinnitus. With Lenire, two neurological pathways are simultaneously stimulated to achieve this result. The auditory nerve is stimulated with music or sounds delivered via Bluetooth headphones while a small electrical impulse is also simultaneously delivered to the tongue to activate the trigeminal nerve, to evoke a somatosensory response. This then allows the brain to retrain itself to focus less on the Tinnitus, thereby reducing its intensity and intrusiveness.
How Severe is Your Tinnitus?
Find out by using this THI (Tinnitus Handicap Inventory) Scoring Calculator
So, the last thing you want when you are trying to achieve this neuromodulation effect is a product that delivers a one-size-fits-all approach to altering management of your nerve signals. Lenire correctly takes a 100% customized approach. From the programming of audio, frequency and intensity of stimulations to even the fitting of the tongue device, it’s all only after a thorough inquiry and diagnosis into one’s Tinnitus condition, by qualified personnel, at approved and qualifying clinics. The device itself allows for active management as well, to cater to user personalization and comfort. The audio can be controlled on a range of up to 12 dB and the strength of electrical stimulation to the tongue can also be controlled via a handheld device.
A minimum of 3 clinic visits are required for this treatment. An initial appointment takes care of a personalized Tinnitus diagnosis and device fitting. A second appointment between weeks 6 and 12 fine tunes or optimizes the treatment, if necessary. A third visit between weeks 12 and 24 explores the potential for continued use of treatment, if necessary.
3 Year Warranty
The device comes with a 3 year warranty. Though treatment in most cases lasts only 12 weeks, it is assuring to know that the device is backed by a reassuringly long warranty, suggesting that it is well made and safe to use.
Study Findings Backed by Tinnitus Hub’s Independent Study
Tinnitus Hub, a popular website that publishes news, articles and content on Tinnitus conducted its own study of Lenire, using 43 participants. The results experienced by this small study audience largely matched or bettered the results provided by the manufacturer’s sponsored clinical study.
In fact, their study provided an additional promising insight that 48% (29 out of 43) of its participants experienced a significant improvement to their THI scores. You can learn more about this independent Tinnitus Hub study here. The study also suggested that participants with sound hearing responded better to the treatment. It also indicated that participants who have both Tinnitus and Hyperacusis also better responded to the treatment.
Disadvantages of Tinnitus Treatment
€2,500 Cost (Not Covered by Public Healthcare Schemes in Europe)
The treatment’s high cost can be a barrier to entry for many patients who might simply not be able to afford it. Also, as neuromodulation treatments are still in a relatively nascent stage of development and acceptance in the medical world, the treatment modalities are not covered by public healthcare schemes, meaning it will come from out of pocket. This may however change in the future.
Lenire is currently available in Ireland, Germany and Belgium and not available in the U.S.A where it waiting on FDA approval. But, even in the U.S.A., it is expected to cost ~$3,000 or more, applying current exchange rates. This again be a fairly obtrusive price point for most people to consider it as a viable treatment option. It is also remains to be seen if American health insurance policies will cover the full or even partial cost of the treatment, when it does become available to purchase.
Requires 60 minutes of consistent use every day, for 12 weeks, to provide optimum results
Any treatment is only as good as the quality with which the user follows recommended treatment protocol. For best results, the Lenire device needs to be used for 60 minutes a day, for 12 weeks. The 60 daily minutes of use can be broken up over two 30 minute intervals a day. The two sessions can be back to back or separate sessions that are any time apart, as long as they performed within 24 hours.
But, the device’s manufacturer recommends that the user follow a routine where the two 30 minute sessions are administered at about the same time everyday.
The device’s manufacturer also recommends that the user shouldn’t watch TV while undergoing the neuromodulation treatment. However, the manufacturer’s website does say that reading a book is OK, if one is compelled to distract themselves while they undergo the session. Users are allowed to lie down although they can’t sleep.
If you are the disciplined sort of person who can follow the above described treatment protocol, these directions won’t be a deterrent. But, if you struggle to keep a habit or are very restless, optimally following recommended treatment protocol can be a challenge, especially over 3 months (12 weeks).
Untested demographics in the clinical study
The clinical study did not include patients who fit the following profile. If you belong to any of these demographic groups, Lenire might be a largely untested treatment protocol for you to consider;
Lenire Clinical Study did not include participants;
- Who suffered from objective Tinnitus (Pulsatile)
- Had tinnitus for more than 5 years
- Who also had conductive or substantial hearing loss
- Who have used hearing aids for less than 90 days
- Have Meniere’s disease
Should You Consider Lenire as a Tinnitus Treatment Option?
This will be completely up to you. We’ve laid out the prominent advantages and disadvantages above. Only you can decide if the cost and potential improvement to your THI scores will be worth the time and money for you.
While you consider Lenire, take a look at our Tinnitus Blog. We constantly publish articles that can help you seek relief and manage your Tinnitus, as much as you possibly can.
