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 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.

People’s experience of tinnitus differs greatly. Most commonly, you will hear it described as an annoying ringing in the ears. You will also hear it described as a buzzing, humming, hissing, or whistling sensation. It can be perceived as being in one or both ears, in the head or even outside the head in certain cases. For many, it’s a constant or fluctuating sound that they will hear all day long – even more so when it’s quiet (such as at night, when there is less external sound to dull it down) – but for others it may be something that comes and goes. Some sufferers will report hearing one single sound whilst others can hear a multitude of sounds. On top of all of these common variations, the sound itself can also vary in both pitch and loudness.

Though not as widely discussed as some other health concerns, the reality is that around 10-15% of a population will experience bothersome tinnitus. To put that into context, if you take the latest population figures from the US (which, in 2019, was just over 328 million), that’s 32-49 million people who will live with tinnitus symptoms. People of all ages can get it; even children. Statistically though, it’s more common in adults as it is associated with hearing loss which is believed to increase with age.

Many people get tinnitus for a short period of time (‘acute tinnitus’ is tinnitus that lasts for a maximum of three months). It can manifest after being exposed to loud music, perhaps at a concert or via headphones, but it can also arise due to an excess in ear wax, or as a result of a cold or a flu. In a lot of these cases, it will pass, but for some, it doesn’t go away, and can be a chronic and bothersome issue.

Generally speaking, there are two types of tinnitus: Subjective Tinnitus and Objective Tinnitus.

Subjective Tinnitus is tinnitus that only the person themselves can hear. This is the most common type of tinnitus, encompassing any and all of the aforementioned symptoms.

Objective tinnitus is tinnitus that your GP can hear when they do an examination and put a stethoscope to the ear. This rare type of tinnitus may be caused by a blood vessel problem or ear muscle contractions.

Lenire is a bimodal neuromodulation treatment that focuses on Subjective Tinnitus; as such, we will refer only to Subjective Tinnitus below.

Hearing loss, as a result of ageing, is the most common cause of tinnitus.

Other common causes include eardrum perforation, middle ear infection, Ménière’s Disease, sudden exposure to loud noise, certain medications, head injury, temporomandibular joint disorder (TMJ) and stress.

Less commonly, tinnitus is linked to hearing loss caused by a blockage or ear condition that affects the outer or middle ear and stops sound waves from passing into the inner ear.

For a lot of people, identifying the specific cause of their tinnitus symptoms proves difficult.

For this reason, it’s important that patients experiencing tinnitus go and see their GP for a full examination in order to diagnose the underlying cause. In some cases, resolving the cause may alleviate the perception of tinnitus, such as an ear infection.

If the GP cannot find an underlying cause, patients may be referred to an ENT Consultant for further investigation. An MRI / CT scan may be carried out to further clarify the problem.

Patients may also be referred on to an audiologist to have their hearing assessed.

Audiologists who specialise in tinnitus can also explain to people the different types of treatments and management techniques available and highlight those which they deem as most suitable to a particular individual.

The majority of people who have tinnitus are not particularly bothered by it; they may find it only mildly annoying and ultimately learn to live with it. For some people, however, living with tinnitus can have a serious impact on their quality of life, triggering anxiety, stress, depression and interfering with hearing, sleep and concentration. Whether it’s mild or severe, the good news is that tinnitus is not a life-threatening condition.

Fortunately, the majority of people find that their tinnitus gets better over time. This is because the brain gradually learns to ‘filter it out’ and not pay attention to it. This process is called ‘habituation’. Habituation is one of the main goals of tinnitus treatment and management therapies.

There is currently no cure for tinnitus but treatments are available that can help reduce the impact of tinnitus so that you can live a normal, active life. The aim of many treatments is to help you manage your tinnitus to the point where it is no longer a problem. Some treatments also aim to reduce the stress that can be associated with tinnitus.

The best way to manage your tinnitus is to visit a trained healthcare professional. The treatment they recommend for each patient will depend on the nature of the tinnitus, how it impacts them, and whether they have any other underlying problems. It may also depend on what is comfortable or acceptable for each patient.

Whichever treatment path is recommended to you, it is important to understand that it can take time for things to improve. Immediate relief may be achieved. Ultimately the aim is to become more comfortable with the tinnitus, to realise that it doesn’t have to effect your quality of life and, most importantly, that you can be in control of it.

Bimodal neuromodulation is the stimulation of not one but two nerves at the same time. With Lenire, for example, you have the combination of electrical 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.

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).

Neuromod’s clinical studies of treatment with the Lenire device 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 to use Lenire (beyond the initial twelve weeks).

Lenire is configured to each patient’s hearing thresholds. 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.

Various research and clinical studies have shown that the combined stimulation of auditory (via the ear) and somatosensory nerves (via the tongue, for example), such as achieved using the non-invasive Lenire device, is more effective when it comes to inducing the positive neuroplasticity important to ease the tinnitus symptoms than stimulating one input at a time. This serves to counter the unhelpful neuroplasticity that gives rise to tinnitus in the first place.

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 after. 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.

Lenire comes with a three year warranty.

• Controller: The expected service life of the Lenire Controller is three years.
• Tonguetip: The expected service life of the Lenire Tonguetip is 180 hours of cumulative use. This means that if you average 60 minutes of treatment per day, your Tonguetip should expire after 6 months of continuous use. This is to ensure cleanliness and the integrity of the electrodes that deliver the stimulation.

Yes, this is a CE marked medical device, classed as low risk and its safety is certified by European regulators (BSI).

The price range of Lenire depends on your prescribing healthcare professional. 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.

Yes. Lenire’s groundbreaking tinnitus treatment technology was granted De Novo FDA Approval following a controlled clinical trial. Sign up for our waiting list — https://www.lenire.com/join-the-assessment-waitlist/ — and an audiologist near you will be in touch as soon as possible.

Lenire is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician and, as a result, is non-refundable. If at any time you are not satisfied with the results, you should discuss with your clinician prior to discontinuing treatment.

If you have any technical issues with your Lenire device, you should contact your prescribing clinician.

Lenire has been proven as a safe and effective tinnitus treatment in clinical trials with more than 600 participants.

• TENT-A1 (Trial 1): This study showed that 86.2% of treatment compliant participants reported an improvement in their THI score after 12 weeks of treatment. 80.1% reporting improvement that sustained for 12 months after treatment.
• TENT-A2 (Trial 2): 91%of compliant patients had sustained relief from tinnitus that lasted 12-months. The average reduction in tinnitus was 20.3 THI points, equal to a full THI grade.
• TENT-A3 (Trial 3): Lenire has been proven to be more effective than sound-alone for the majority of people with moderate or worse tinnitus.
• All Trials: Across all clinical trials, 83% would recommend Lenire to treat tinnitus.

Lenire also conducted real world trials with more than 200 people. The results of Lenire’s real world trials closely matched clinical trial results.

No. Lenire is customised on a per patient basis and should only be used under the guidance of an approved hearing care professional. As a result, acquiring a second hand Lenire Device is prohibited, even if the device has not been used by the patient it had originally been prescribed for.

Lenire is customised on a per patient basis following a tinnitus assessment and should only be used under the guidance of an approved hearing care professional. 

As a result, a third party cannot acquire Lenire on your behalf.

Lenire should be used for two soothing 30-minute sessions per day using Lenire. Lenire sessions can be at different times of the day (morning and evening, for example) or back to back.

The total treatment timeline for Lenire is prescribed by a Lenire Qualified Healthcare Professional.

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 device 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 Lenire. 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. Falling asleep during a treatment session is not advised.

Where possible, the patient should try to keep a routine for the treatment sessions, where Lenire is used in or around the same time (or times) each day. Using Lenire 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 device 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.

We recommend using the headphones provided for the treatment only.

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.

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).