Lenire: A New Approach to Tinnitus Treatment

Lenire, a product of Neuromod Devices Ltd, is an evidence-based treatment device designed to soothe tinnitus. This device uses a novel approach known as bimodal neuromodulation to mitigate the symptoms of tinnitus.

The concept of bimodal neuromodulation revolves around the simultaneous stimulation of two types of nerves. In the case of Lenire, these are the auditory nerves (via sound) and the trigeminal nerve (via mild electrical impulses on the tongue).

Components of the Lenire Device

Lenire consists of three main components:

• Tonguetip: A specially designed component that sits comfortably within the mouth. It contains tiny electrodes that deliver mild electrical pulses to the surface of the tongue, thereby stimulating the trigeminal nerve.
• Bluetooth Headphones: These headphones deliver customized sounds designed to stimulate the auditory nerves, transmitting signals to the brain.
• Controller: A handheld device that allows users to manage the timing and intensity of the treatment. The controller enables users to start, pause, and resume the treatment session. It also allows adjustment of the sound volume and the level of tongue stimulation.

The settings on the Lenire device are customized by a qualified healthcare professional to suit an individual's specific tinnitus condition.

Lenire Tinnitus Treatment Process

Learn more about our tinnitus treatment protocol at Silicon Valley Hearing in Los Gatos

1. Initial Tinnitus Assessment

At your initial tinnitus assessment, our clinical team will evaluate your suitability for Lenire. This assessment includes diagnostic audiological evaluation, a thorough tinnitus assessment, education and guidance on tinnitus, treatment recommendations and the creation of a personalized treatment plan tailored to your needs.

2. Device Fitting Appointment

If we recommend Lenire, we'll personalize your device and Tonguetip based on your hearing profile, ensuring the treatment is tailored to your specific needs. This process also involves device usage training, supervised initial use before home use and the creation of a personalized tinnitus education and guidance plan.

3. Follow-ups and check-ups

During your follow-up assessments, our team will evaluate your progress with Lenire. As part of your Lenire treatment plan, you are entitled to up to three follow-up assessments.
These assessments include:
- Repeated audiological and tinnitus evaluations, as needed
- Adjustments to optimize the settings of the Lenire device for maximum potential benefit
- Guidance for continued use at home
- Development of a personalized tinnitus education and guidance plan

4. Continued use of device

Upon the completion of your recommended treatment plan, our team will provide guidance on how to continue using the Lenire device at home.

The Science Behind Lenire: How Does It Work?

Lenire works by delivering sounds via headphones and gentle electrical pulses on the tongue simultaneously. This combined stimulation helps to retrain the brain, reducing the focus on the tinnitus and thereby lessening its impact on daily life. This strategy hinges on the concept of neuroplasticity, which refers to the brain's ability to adapt to new experiences and learn from them. By fostering positive neuroplasticity in areas of the brain associated with tinnitus, Lenire facilitates a significant reduction in tinnitus symptom severity.

The Research Supporting Lenire: Clinical Trials & Success Rates

Lenire's effectiveness as a tinnitus treatment device has been proven through extensive clinical trials. It is the first device of its kind to receive a grant of approval from the FDA for tinnitus treatment. The large-scale clinical trials conducted to meet the FDA's stringent requirements revealed that 83% of patients recommended Lenire for tinnitus treatment. These trials' results were consistent with real-world evidence gathered from over 200 patients, further reinforcing Lenire's effectiveness. See https://www.lenire.com/clinical-trials/ for more information.

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UPDATE: The TENT A-3 Clinic Trial

The TENT-A3 clinical trial, published in Nature Communications, evaluated the effectiveness of Lenire, a bimodal neuromodulation device for tinnitus treatment. This controlled trial involved 112 participants with an average age of 48.9 years and an average tinnitus duration of 4.3 years. The study compared six weeks of sound-alone therapy to six weeks of Lenire's bimodal neuromodulation, which combines sound with mild electrical stimulation of the tongue.

The results demonstrated that Lenire was more effective than sound-alone therapy for those with moderate or worse tinnitus. Notably, 70.5% of participants who did not benefit from sound-alone therapy experienced clinically meaningful improvement with Lenire. The trial also reported no device-related serious adverse effects, and 88.6% of patients would recommend Lenire for tinnitus treatment. These findings were instrumental in Lenire receiving FDA approval in March 2023, marking it as the first and only FDA-approved bimodal tinnitus treatment device.

The Lenire Experience: Patient Success Stories

A significant number of patients who have used Lenire for tinnitus treatment have reported positive outcomes. The treatment has not only mitigated the severity of their tinnitus but also improved their overall quality of life. By reducing the constant noise associated with tinnitus, Lenire has empowered individuals to regain control of their lives, allowing them to enjoy social activities, concentrate better, and experience more restful sleep.

Is Lenire the Right Solution for You?

While Lenire has proven to be a promising solution for tinnitus, it's crucial to remember that tinnitus is a complex condition and the effectiveness of treatment can vary from one individual to another. Therefore, an assessment by a healthcare professional is required to determine the suitability of Lenire as a treatment option.

Accessing Lenire: Your Path to Tinnitus Relief

Silicon Valley Hearing, based in Los Gatos near San Jose, is proud to be one of the first providers of Lenire in the United States. We are currently the only Lenire provider in Santa Clara County. Led by Dr. Marni Novick, who herself has experienced hearing loss and tinnitus, our team understands the challenges that come with tinnitus. We're committed to providing compassionate, informative, and empathetic care to those seeking relief from tinnitus.

A New Hope for Tinnitus Sufferers

While there is currently no definitive cure for tinnitus, advances in technology, such as Lenire, are providing new hope for those suffering from this condition. Lenire's innovative approach to tinnitus management, backed by rigorous clinical trials and glowing patient testimonials, marks a significant step forward in the quest for effective tinnitus relief. By offering a non-invasive, home-based treatment solution, Lenire is not only alleviating tinnitus symptoms but also transforming lives.

If you’re in the Los Gatos, San Jose, Saratoga, Campbell, Santa Cruz, Cupertino or Santa Clara areas and are looking for tinnitus relief or to schedule an assessment, please contact us today. We're ready to guide you on your journey towards improved hearing and a better quality of life.