Lenire™ User Manual

This manual is supplied with the Lenire™ device to provide you with information on the product, treatment regime and instructions for its safe and effective use. In addition, it includes important safety information and instructions which you should read and understand before use.

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Is Lenire™ for me? Evidence-based treatment to soothe and relieve tinnitus.

Is Lenire™ for me?

At this time Lenire™ is only approved for sale in Europe. Lenire™ will be rolled out gradually through audiologists and physicians, who are knowledgeable and experienced in the treatment of tinnitus. Lenire™ is available through Neuromod Medical in Dublin, Ireland.

The Potential Benefits:
Lenire™ has reduced average tinnitus scores in four clinical trials to date. In two recent randomised clinical trials more than two thirds of participants reported clinically meaningful improvements when using the optimised device setting. On average these improvements were maintained after the clinical trial participants had stopped using the device.

Ease of Use:
Clinical trial participants found Lenire™ comfortable, convenient to use and easily incorporated the treatment into their daily routine.

Proven Results:
Lenire™ is the only tinnitus treatment device that has achieved consistent results in multiple prospective clinical trials. More than 500 volunteers have participated in clinical trials sponsored by Neuromod. No other medical device company has invested in gathering so much clinical evidence for the treatment of tinnitus.

Request a consultation to see if Lenire™ is right for you. An audiologist or otolaryngologist experienced in the treatment of tinnitus will conduct a number of standard assessments and discuss treatment options with you.

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2/3

In recent large clinical trials at least 2 out of every 3 participants reported clinically meaningful improvements

90%

90% of TENT-A2 participants used the treatment as directed for at least 10 weeks

500+

Neuromod has invested in clinical trials involving more than 500 participants

FAQs

Lenire™ is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. Evidence from clinical trials indicates that Lenire™ can soothe and relieve tinnitus when used in accordance with the instructions for use. However, as with all medical treatments, many factors may influence the result. If you are not satisfied with the results, consult with your clinician who may change the settings of Lenire™ or recommend an alternative course of treatment.

There are many different subtypes of tinnitus. Pulsatile tinnitus is described as a noise that is rhythmic and seems to follow a steady beat. In some cases, the underlying cause of the noise can be identified and treated separately. Where an underlying cause cannot be identified, Lenire™ may be considered by your clinician. To date, Lenire™ has not been thoroughly evaluated in pulsatile tinnitus without an underlying cause. If you experience tinnitus as a pulsatile noise you should discuss with your clinician.

Each person’s experience of tinnitus can be different. If you hear different sounds consult your clinician to find out if Lenire™ is recommended for you.

Lenire™ is a medical device used as part of a treatment plan supervised by a qualified and experienced clinician. If at any time you are not satisfied with the results, you should discuss with your clinician prior to discontinuing treatment. Depending on the duration of treatment completed, your clinician may be able to offer you reduced treatment costs if you choose to discontinue. Lenire™ is not a consumer device and so no money back guarantee can be offered.

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. To find out more about the cost of the treatment programme, please visit your local clinic

Lenire™ is not yet available in the United States.

Healthcare Professionals

If you are a Healthcare Professional involved or interested in treating tinnitus and would like to learn more about how to incorporate Lenire™ into your practice, please register for information.

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