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What is Lenire? Convenient and easy to use in the comfort of your home, Lenire is a breakthrough new treatment for tinnitus.

What is Lenire?

Lenire is a non-surgical device, designed for use by patients in the comfort of their home after being fitted and evaluated by an appropriately qualified healthcare professional.

This bimodal neuromodulation treatment combines sound stimulation to the ear with gentle electrical stimulation to the tongue to promote therapeutic, positive neuroplasticity in tinnitus patients. This serves to counter the unhelpful neuroplasticity that gives rise to tinnitus in the first place. 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.

The Lenire system has been shown — in trials involving more than 500 participants — to reduce and soothe the symptoms of tinnitus. In essence, Lenire is retraining the brain to reduce its attention and sensitivity to the tinnitus sound that was previously active in the brain. Lenire presents different sounds and stimulus patterns on the tongue, which activates different cells and regions in the auditory pathway of the brain, as well as other emotional and cognitive regions in the brain.

This diverse activity in the brain not only interferes with the ongoing activity caused by tinnitus, but also makes the brain pay attention to the novel or changing stimuli that are being continuously presented to the individual by the Lenire device, leading to an individual being less aware or bothered by their tinnitus. A novel feature of Lenire is the combined presentation of the two inputs (sound and tongue stimulation) that drives stronger and more helpful 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 input at a time.

The Device Components

Lenire is a CE-marked medical device with three main parts

The Lenire Controller

A lightweight handheld device that controls the timing and intensity of the treatment. You can start, pause and resume the treatment session, adjust the volume of the sound, adjust the level of the tongue stimulation.

Tonguetip

This is a proprietary intraoral device, ergonomically designed to sit comfortably in the closed mouth. Tiny electrodes on the tonguetip deliver mild and safe energy pulses to the trigeminal nerves via the surface of the tip of the tongue.

Headphones

Lenire must be used with the set of wireless, Bluetooth headphones, which are provided as part of the package. The headphones are paired to the controller and deliver customised sounds to stimulate the auditory nerve.

AKG is a registered trademark of Harman International-Harman International, is a wholly-owned subsidiary of Samsung Electronics Co, LTD. AKG Headphones are supplied with the Lenire device.

Also included in the packaging

User Manual – Supplied with the Lenire system to provide information on the product, the treatment regime and instructions for its safe and effective use.

Quick Start Guide – Outlines the basic steps needed to commence a treatment.

Charger – Charger provided with the system is used to charge the controller and the headphones

Carry case – The carry case is a portable case which can be used to store the controller and the tonguetip in between uses. Designed to protect them from damage and maintain cleanliness.

The Treatment

 

What can you expect from the experience of using Lenire?

Lenire is intended for prescription use only. If Lenire is deemed suitable and thus prescribed for you by an appropriately qualified healthcare professional, the audio and tongue stimulation will be configured and calibrated to your individual characteristics during the initial fitting procedure. Once you are comfortable with the treatment, having been shown what to do with the various device components during your first fitting, you can then proceed to use Lenire in the comfort of your own home or at your preferred location.

The treatment plan advises daily home use of the device over the course of at least three months. Lenire is recommended to be used for 30 to 60 minutes per day, and used for a minimum of 12 weeks. 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.

After 12 weeks of consistent use, you will then attend a follow up visit with your prescribing clinic where your healthcare professional will assess your progress and discuss your options for continued use. It is possible to continue with the treatment, but it’s also possible that there would be no such need to do so; either way, your healthcare professional will advise. If you have any issues throughout your course of treatment, it’s important to communicate with your healthcare professional as a visit may be required in which your stimulation settings are adjusted for your comfort.

How has the Treatment helped you?

Since I did the Neuromod program, I’m much calmer and relaxed about it….the biggest thing for me is that my focus on the sounds isn’t there as much

Ronnie, Clinical Trial Participant

How has the Treatment helped you?

About six weeks through the trial, I realised that the intensity of my tone that I was experiencing in my ear had completely reduced

Aidan, Clinical Trial Participant

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