Frequently Asked Questions
Neuroplasticity is the ability of the brain to change or rewire itself continuously throughout a person’s life by forming new networks and pathways. Neuroplasticity can be helpful (adaptive), such as our brain’s ability to learn a new language. It can also be unhelpful (maladaptive). For example, when our brain attempts to rewire itself as a result of damage due to hearing loss, which is believed to lead to tinnitus symptoms, this would be a maladaptive effect of neuroplasticity.
Neuromodulation is a relatively new therapeutic treatment which can be used for a wide variety of conditions including pain and depression. It works by alternating nerve activity by delivering a stimulus (such as low levels of electric energy) which then alters or adjusts the activity within the body or the brain to improve the specific health condition. Most recently, neuromodulation has emerged as a potential and promising treatment for the management of tinnitus.
Bimodal neuromodulation is the stimulation of not one but two nerves at the same time. With Lenire, for example, you have the combination of what’s known as trigeminal stimulation via the tongue as well as auditory stimulation via the ear. Research has suggested that the combined stimulation of these two nerves drives stronger adaptive neuroplasticity, which in turn can reduce the brain’s attention and sensitivity to the tinnitus sound to a greater extent than when stimulating only a single nerve at a time.
The trigeminal nerve stimulation via the tongue is used for two main reasons:
- The trigeminal nerve is easy to stimulate. There’s little preparation necessary. What’s more, it’s non-invasive, requiring nothing more than the use of the Tonguetip® device which sits on the tongue.
- The trigeminal nerve and the auditory nerve are intertwined in the cerebral cortex, allowing for maximum effect.
If fitted with a hearing aid in the last 90 days, then it is not recommended to start Lenire until after a 90 day period. This allows for adequate time in which the person can adjust to the hearing aids and see if they work. Patients are advised to take out the hearing aids for one hour before treatment, and leave aid(s) out for an hour afterwards. This is merely a precaution to avoid over-stimulating the auditory nerve.
Lenire is configured to each patients hearing threshold, once configured the volume of the treatment can be reduced or increased by a maximum of 12 decibels if required. Where sound intolerance is an issue, it is advised that you discuss this with your Healthcare Professional before starting treatment.
Neuromods clinical studies of the Lenire treatment ran for a 12 week period. Some patients may see results as early as 6 weeks and for some it may take 12 weeks or longer. Upon completing the 12 week course, you will reassess your symptoms with your healthcare professional who will then advise you as to whether or not you would benefit from continuing with the Lenire treatment (beyond the initial twelve weeks).
Lenire is recommended for patients with subjective tinnitus (where the sound or ringing sensation is only audible to the person experiencing it, regardless of the type of sound they are hearing).
It is recommended that you store your Tonguetip® in the carry case provided as part of the treatment package. It’s important, at all times, to store the Tonguetip® in a clean, dry location where it is not in contact with chemicals, foods, liquids or animals.
It is advisable to clean the Controller, the Headphones, the Carry Case
and the tonguetip after prolonged disuse or storage, or after exposure to
conditions that could affect their hygiene.
The Tonguetip® should be cleaned using either water or a 70% Isopropyl Alcohol (IPA) wipe, as per the instructions provided in the Lenire User Manual. Following cleaning, gently wipe away any residual water or IPA with a clean lint-free cloth and leave to air-dry if you’re not using the device for a treatment session immediately thereafter. It is important that no other cleaning agents are used (e.g. detergents, baking soda, bleach, vinegar) to avoid damage to the Tonguetip®.
No. The Lenire device is tailored specifically for each patient based on their hearing profile. Therefore, the device needs to be prescribed/purchased through qualified Healthcare Professional after a detailed tinnitus consultation. Assuming Lenire has been recommended for an individual, it’s also important that the treatment is demonstrated and explained to each patient by the relevant clinician during their initial consultation prior to beginning the treatment itself (so as to ensure that the patient is comfortable and confident using Lenire).
The Tonguetip® will expire after 180 hours of cumulative use, this means that if you average 60 minutes of treatment per day, you should expect your Tonguetip® to expire after 6 months of continuous use. This is to ensure cleanliness and the integrity of the electrodes that deliver the stimulation.
The device comes with a three year warranty. The expected Service Life of the controller and Tonguetip® is three years.
Yes, this is a CE marked medical device, classed as low risk and its safety is certified by European regulators (BSI).
Lenire is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. Neuromod Devices manufactures the device and offers guidance to clinicians about the recommended retail cost of the treatment, however, each clinician will determine the price of the treatment programme, taking into account the cost of their time and expertise as well as the device itself. To find out more about the cost of the treatment programme, please visit your local clinic.
Lenire is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. If at any time you are not satisfied with the results, you should discuss with your clinician prior to discontinuing treatment. Depending on the duration of treatment completed, your clinician may be able to offer you reduced treatment costs if you choose to discontinue. Lenire is not a consumer device and, as such, no money back guarantee can be offered.
It is recommended to carry out two thirty minute sessions per day using Lenire; these two sessions can be separate or experienced back to back (creating one 60 minute session) - whichever you prefer.
You will have an initial fitting appointment, one at 6 to 12 weeks to assess how you are getting on and make any necessary adjustments and one more at 12 to 24 weeks to decide, with your healthcare professional, if you would benefit from continued use of Lenire. Of course, if any issues arise, extra appointments can be arranged.
No. As the treatment is configured specifically for each patient, based on their audiological profile, we do not recommend sharing the device with another person.
It is recommended that each session is completed in an environment that is both quiet and conducive with relaxation. The patient should be sitting comfortably while using the treatment. Focusing attention away from distractions such as the TV may improve the effectiveness of the treatment. If the patient is struggling to relax for the 30 minute duration, they can read.
There is no issue with using Lenire while lying down, as long as there is no chance of falling asleep. We do not recommend falling asleep using the treatment as the tonguetip may fall out unknowingly.
Where possible, the patient should try to keep a routine for the treatment sessions, where the treatment is delivered in or around the same time (or times) each day. Using the treatment in the morning and the evening is a popular routine, but consistency is more important than the specific time of day.
Lenire has been designed for use with the headphones provided with the device at the time of sale. The system will not stream to other Bluetooth audio devices, such as speakers. The treatment has been shown to be effective through the use of headphones other audio devices have yet to be tested.
If you have any technical issues with your Lenire device, you should contact your prescribing clinician or contact Neuromod Devices technical support at firstname.lastname@example.org.
We recommend using the headphones provided for the treatment only.
Lenire should only be used with the headphones provided. The reason being is that our device is configured to only pair with the model of headphones provided.
This is recalibrated at each appointment. The patient can make the Tonguetip® stimulus either weaker or stronger on the device themselves, although this has no effect on the treatment overall and is purely a case of personal preference.
It usually takes about 3 to 4 hours to fully charge the controller. When the battery indicator light is flashing green, it is fully charged. When fully charged, the device should operate for roughly 20 treatment sessions before recharging is necessary.
It usually takes between 2 and 3 hours to fully charge the headphones. When they are fully charged, the red light beside the headphones’ charge port will turn off. When fully charged, the headphones should operate for roughly 12 treatment sessions before recharging is necessary.
Yes, the supplied charger (XP Power model VEP08US05-XE0767) can be used to charge the headphones as well as the controller.
The audio is configured by the clinician based on your hearing characteristics. Depending on your progress with the treatment, your clinician may offer to change the stimulus at follow-up clinic visits, which in some cases may require the audio to be changed.
No. There is currently no means by which alternative audio tracks can be incorporated into the Lenire device. Should this change, Lenire customers will be notified in due course.
In your treatment consultation with your healthcare professional, the device will be set to the optimum level according to your hearing thresholds. You can increase or decrease the volume by using the volume control buttons on the device. If you are sensitive to sound you should inform your healthcare professional.
The Lenire proprietary audio was composed and produced by Neuromod Devices (the manufacturer of the Lenire system).