Lenire is a new bimodal neuromodulation device for tinnitus shown to reduce the symptoms and improve the experience of those living with tinnitus.
Lenire is a non-invasive home-use medical device that has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional.
Your audiologist at The Tinnitus Clinic will evaluate your tinnitus and determine if Lenire is right for you. If Lenire is recommended, your clinician will prescribe a treatment plan that typically includes two daily 30-minute sessions and at least two follow up visits with the first approximately 6 to 12 weeks after you start using Lenire and the second 6 to 12 weeks after your first follow up. During these follow up visits your clinician may adjust device settings to optimise the potential for relief.
A recent clinical trial showed that 91%** of participants who used Lenire as directed achieved an improvement of their Tinnitus Handicap Inventory score that was sustained for 12 months after treatment.
* Read FDA approval press release here
** TENT-A2: Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.
My hope with the device was to try and reduce the level of tinnitus...
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‘My hope with the device was to try and reduce the level of tinnitus back to a level where I was comfortable, like prior to when I had the ear infection and from using the device that’s where I am now, I’m back to a situation where my tinnitus is much less prominent, much less distracting. The tinnitus did affect my interest in music because you say to yourself what’s the point if I’m not hearing properly. I can now go back to doing things that I wasn’t able to do over the past few years – writing and recording music. Going on the results I have I would recommend it.’
‘My tinnitus now is at a level (where) I just take no notice of it. I just found, I don’t hear it. I just don’t hear it all, so for me that Lenire device has been a lifesaver.’
‘After about a month, I noticed that it started working...
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‘After about a month, I noticed that it started working, and funny enough I noticed it when I didn’t use it. I had to go to the dentist and got some treatment on my teeth – I wasn’t able to use the device so I had to pause it for about 5 days and then within 5 days I just noticed that my tinnitus increase and when I started using it again I started paying attention to how it was dropping to the lower levels. At the worst my tinnitus was about a 7 or 8 out of ten, and after using Lenire for around a year, it has dropped to like 1 or 2. It’s very handy for me to use Lenire during my work as I can just plug away and just do the treatment while I’m working. Back when the tinnitus was really bad, I started questioning my music industry job, and I stopped going to the gigs, music events and I started thinking about that I no longer will be able to participate in any events, but now I’m able to book tickets again. If anyone in the music industry and have suffering from tinnitus I would definitely recommend the Lenire treatment as it is something that helped me a lot.’
‘If ten was [how severe my tinnitus was] in 2015, tinnitus now is one, maybe two out of ten...
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‘Sometimes I just have this feeling in my head, this is a Lenire moment, I use it and then get the relief or comfort from it.
I no longer worry about this tinnitus distressing me when I’m with friends….now I’ve full control of it.
I definitely recommend it, it changed my life. I’m definitely more relaxed, it has to be because of Lenire.’
* Testimonials supplied by Lenire®. The Tinnitus Clinic is a Lenire Partner. You can book an Initial Assessment so that we can assess your suitability for Lenire®
Customised sounds are played through Bluetooth® headphones to activate the nerve involved in hearing (the auditory nerve).
Mild and safe energy pulses are delivered to the surface of the tip of the tongue to activate touch nerves to the brain.
The activated nerves convert the sound and the energy pulses into signals that are relayed to the brain, where over time the unique signal patterns work to reduce and soothe the perceived tinnitus experience.
Lenire is intended for prescription use only. If Lenire is deemed suitable and thus prescribed for you by your Tinnitus Clinic audiologist, the audio and tongue stimulation will be configured and calibrated to your individual characteristics during your fitting appointment. Once you are comfortable using the device, having been shown how to use the various device components during your fitting, you can then proceed to use Lenire from the comfort of home.
A typical treatment plan advises daily home use of the device for a minimum of 10 weeks. Lenire is recommended to be used for 30 to 60 minutes per day. It’s important that each session is completed in a place that is quiet and comfortable; the more relaxed you are during the treatment, the better. This includes feeling physically comfortable in a seated position during the session. Where possible, you 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.
Your Tinnitus Clinic audiologist may follow up with you at regular intervals over a period of months or years. A follow-up appointment is advised within 6 to 12 weeks of your fitting with a second follow up taking place 6 to 12 weeks after the first follow up. This allows your progress to be assessed as you progress through your treatment plan. At the end of your prescribed treatment plan, your Tinnitus Clinic audiologist will advise you about continued use of Lenire. If you have any issues during your treatment plan, it is important to communicate with The Tinnitus Clinic as a visit may be required so that your stimulation settings are adjusted for your comfort.
91% of patients in Lenire’s 2nd large trial averaged a 20.3 point reduction (THI) in tinnitus that lasted for at least a year after the trial.2
Reducing tinnitus from 51.2 (moderate) to 30.9 (mild) on average, for example, is a huge quality of life improvement.
Tinnitus Handicap Inventory is a clinical standard for measuring tinnitus. Measured on a scale of 1 – 100, higher scores means worse tinnitus. Decreasing THI leads to an improved quality of life for tinnitus patients.
95% of compliant TENT-A2 tinnitus clinical trial patients reported improvement when evaluated after 12 weeks.**
91% of TENT-A2 participants saw sustained improvement in tinnitus severity when evaluated at 12-months post-treatment.**
Lenire has shown to provide clinically significant relief from tinnitus in clinical trials involving more than 600 participants.^
1. TENT-A1 Conlon et al., Sci. Transl. Med. 12, eabb2830 (2020)
2. TENT-A2: Conlon et al., Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial, Sci Rep.
3. TENT-A3: Clinical trial data in preparation for independent publication: clinicaltrials.gov/ct2/show/NCT05227365.
4. Aggregate: TENT-A1, TENT-A2, TENT-A3 aggregate clinical trial results.
Note 1: All statistics based on compliant patients. Patient compliance criteria is detailed in Lenire’s clinical trial design.
Note 2: TENT-A1/TENT-A2 were not considered by the United States of America FDA as part of Lenire’s FDA Grant and, as such, applies solely to outside the US.
To understand how Lenire works, first we look at the science of neuromodulation. Neuromodulation in its modern form is a therapy that has been used successfully for a wide variety of health and brain conditions, from physical pain and epilepsy to movement disorders and depression. Most recently, it has emerged as a potential treatment for the symptoms of tinnitus. Simply put, neuromodulation aims to alternate neural activity through a targeted delivery of a stimulus, such as stimulation of a nerve. It works by targeting a specific nerve or brain region with a stimulus, such as low levels of electrical energy, in order to alter or adjust the activity within the body or brain to improve a health condition.
Lenire, a clinically proven treatment device for tinnitus, takes neuromodulation one step further by stimulating two nerves at the same time. This is known as ‘bimodal neuromodulation’.
Various research and clinical studies have shown that the combined stimulation of auditory (via the ear) and somatosensory nerves (via the tongue, for example), which is 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.
This particular bimodal neuromodulation technology- which is the first commercially available deviceof its kind - combines sound stimulation to the ear with gentle electrical stimulation to the tongue. The signals are coordinated through the Lenire control device, which plays soothing sounds through the recommended headphones while sending electrical pulse signals through the Tonguetip device. The Tonguetip rests on the tip of the patient’s tongue. This diverse activity in the brain not only interferes with the ongoing activity caused by tinnitus, but also makes the brain attend to the novel or changing stimuli that are being continuously presented to the individual, leading to an individual being less aware or bothered by their tinnitus.
To date, clinical trials involving more than 600 participants using Lenire have taken place. Neuromod Devices’ published TENT-A2 study showed that 95% of treatment compliant participants reported an improvement in their THI score after 12 weeks of treatment. 91% of TENT-A2 participants saw sustained improvement in tinnitus severity when evaluated at 12-months post-treatment.
For a full treatment programme including the Lenire device: £3,595. Finance is available – details here.
The Tinnitus Clinic Limited
Bentinck House,
3-8 Bolsover Street,
London
W1W 6AB
0800 030 6617
info@thetinnitusclinic.co.uk
Care Quality Commission
Registered No. 1-320031644
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