Frequently Asked Questions

Yes. Health Savings Account (HSA) and Flexible Spending Account (FSA) funds can be used to pay for Lenire. Both account types allow you to use pre-tax dollars to pay for eligible healthcare expenses.

Because Lenire is a prescribed medical device, it is considered an HSA/FSA-eligible expense. 

HSA and FSA funds can be used for family members.  

You may also be able to use HSA or FSA funds to pay for appointments related to your Lenire treatment, such as your tinnitus evaluation, fitting appointment, and follow-up visits.  

We recommend checking with your healthcare provider and your HSA or FSA plan administrator to confirm your eligibility and any documentation that may be required. 

A Health Savings Account (HSA) is available to individuals enrolled in a qualifying high-deductible health plan (HDHP). The funds belong to you, roll over from year to year, and stay with you even if you change employers. 

A Flexible Spending Account (FSA) is typically offered through an employer. Like an HSA, it allows you to use pre-tax dollars for eligible medical expenses. However, FSA funds are generally subject to a “use-it-or-lose-it” rule, although some plans offer a grace period or allow a limited amount to roll over. 

For more information about HSA and FSA accounts, visit HealthCare.gov: 

• Health Savings Accounts (HSAs) 

• Flexible Spending Accounts (FSAs) 

Insurance coverage for Lenire varies by health plan. At this time, Lenire is not broadly covered by major commercial insurance plans or Medicare in the United States. 

We encourage you to contact your insurance provider directly to determine whether your plan provides any coverage for Lenire or for the appointments associated with your treatment. If needed, your healthcare provider may be able to provide documentation to support your inquiry. 

If you have a Health Savings Account (HSA) or Flexible Spending Account (FSA), you may be able to use those funds to help pay for Lenire and related treatment appointments. Please see our HSA/FSA FAQ for more information. 

Yes. many Lenire providers in the United States accept third-party medical financing, such as CareCredit and Cherry, allowing eligible patients to pay for treatment over time. 

Financing options vary by provider, so we recommend asking your Lenire provider about available payment plans and financing programs during your consultation.

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.

Watch Neuromod Technical Support Expert, Dr. Beth Field give an Intro to Tinnitus on Talking 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.

Watch Neuromod Clinical Training Manager, Dr. Sarah Matthews discuss Different Types of Tinnitus on Talking Tinnitus.

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.
• Objective Tinnitus is tinnitus that your doctor can hear during an examination. This rare type of tinnitus may be caused by a blood vessel problem or ear muscle contractions.

Lenire is a bimodal neuromodulation device that treats Subjective Tinnitus. As well as the two many types of tinnitus, there are also subtypes – Somatic Tinnitus, Cochlear Tinnitus, and Central Tinnitus.

• Somatic or Somatosensory Tinnitus is when tinnitus changes in pitch, volume, location, or the type of sound you hear when you move your head, neck, jaw, or face. TMJ and other dental issues such as bruxism or malocclusion, cervical, spinal, and head injuries, and even muscle tightness are all causes of somatic tinnitus. Somatic tinnitus is present in 65 to 80% of people with tinnitus.
• Cochlear Tinnitus occurs when something affects the health of the ear resulting in abnormal neural activity in the cochlea, resulting in the perception of tinnitus. Hearing loss, noise exposure, ototoxic medications, ear diseases, and medical conditions such as diabetes and cardiac conditions are all common causes of cochlear tinnitus.
• Central Tinnitus is when abnormal patterns of spontaneous activity in the auditory brain center result in tinnitus. The activity typically begins when tinnitus has become a chronic condition. Once this occurs, the brain starts to react to the presence of somatic and cochlear tinnitus. We can see these changes start to occur as soon as 12 weeks (about 3 months) after the start of tinnitus.

If you are experiencing tinnitus, it is recommended to seek advice from a medical professional with an understanding of tinnitus. You can find a tinnitus specialist near you by visiting www.lenire.com/find-a-clinic/.

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.

Watch Peachetree Hearing Owner, Dr. Melissa Wikoff discuss when you should seek help for tinnitus on Talking Tinnitus.

Identifying the specific cause of tinnitus can be challenging.

Resolving tinnitus causes such as an ear infection, or a build up of earwax may provide relief from tinnitus. However, as there are many causes of tinnitus, it is recommended that people who notice tinnitus should speak with an audiologist that specialises in tinnitus care.

A tinnitus specialist can conduct a tinnitus assessment to diagnose the underlying cause of tinnitus. They can also explain management techniques or treatment options, such as Lenire.

You can find an audiologist that specializes in tinnitus care by visiting www.lenire.com/find-a-clinic/.

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.

Watch Tobias & Battite Hearing Wellness Tinnitus Expert, Dr. Miles Sabine explain What’s in a Tinnitus Assessment and why they’re so important for managing tinnitus on Talking Tinnitus.

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.

Watch Neuromod Founder and CEO, Dr. Ross O’Neill explain bimodal neuromodulation on Talking 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 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.

Watch Neuromod Clinical Training Manager, Dr. Sarah Matthews discuss Different Types of Tinnitus on Talking Tinnitus.

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).

Watch Tinnitus Treatment Center Philadelphia Owner, Dr. Gail Brenner explore Common Tinnitus Issues on Talking Tinnitus.

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.

Watch New York Hearing Doctors’ Dr. Craig Kasper answer “Is Tinnitus Treatable?” on Talking Tinnitus.

No but tinnitus is treatable. Lenire is clinically proven to provide relief from tinnitus. Lenire’s clinical trials have demonstrated that the medical device is effective at soothing tinnitus. Additionally, Lenire has been proven to be more effective than audio-only therapy at soothing tinnitus.

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 is FDA Approved and is available at specialized clinics across the United States of America. You can find a clinic near you using Lenire’s Find a Clinic Map. You can also fill out the Assessment Waitlist Form if there are no specialized Lenire Providers near your location.

Lenire was awarded a De Novo Grant from the US Food and Drug Administration following the success of the tinnitus treatment device’s third large scale clinical trial, TENT-A3. TENT-A3 was a controlled clinical trial that involved 112 participants.

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): 70.5% of people with moderate or worse tinnitus reported clinically significant improvement after sound-alone had no meaningful impact*.
• 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.

*https://www.nature.com/articles/s41467-024-50473-z

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).

Yes. According to the Annual Benefits Report (ABR), 3.2 million Veterans are living with tinnitus. The number of Veterans with tinnitus is growing by 12% every year.¹ Tinnitus is the #1 service-connected disability for US Veterans and has been since The Vietnam War.

1. US Annual Benefits Report US VA Benefits Report Fiscal Year 2024: https://www.benefits.va.gov/REPORTS/abr/docs/2024-abr.pdf

Yes. Lenire is a treatment option through Veterans Affairs (VA). You can find a VA Clinic that has Lenire available as a treatment option by visiting https://www.lenire.com/lenire-for-veterans/.

Lenire is prescribed after an assessment by an appropriately qualified clinic. Your treating clinician may recommend other treatment options based on your assessment.

Lenire is a treatment option through Veterans Affairs. However, as Lenire has been made a treatment option recently, many clinics do not yet offer Lenire.  Veterans who wish to be assessed for Lenire are advised to inquire about the tinnitus treatment device at their local VA Clinic. 

Lenire is only prescribed after an assessment by an appropriately qualified clinic. Your treating clinician may recommend other treatment options based on your assessment.

Hearing loss is the #1 cause of long-term tinnitus. There are many additional causes. These include, but are not limited to:

• Aging
• Exposure to Loud Noise
• Ear Infections
• Méniere’s Disease
• Damage to the Hearing System
• Earwax Buildup
• Jaw / Neck Issues (e.g. TMJ)
• Medication Side Effects

Tinnitus in Veterans may have additional factors. Learn more about Veterans and tinnitus at the Veterans Health Library.

Visit the VA,gov website or watch this video for more information on how to file a claim through Veterans Affairs.