Neuromod Lenire Manuel De L'utilisateur page 4

Section A
General information
This section outlines the general information relating to the Lenire
including important safety information.
Chapter 1 - Introduction
Lenire is a medical device intended to reduce the symptoms of tinnitus. It comprises a handheld
Controller and a Tonguetip® which, delivers gentle, electrical stimulation to the tongue, and
is used in conjunction with wireless Headphones that deliver audio stimulation. A Charger is
included that can be used to charge both the Controller and the Headphones.
The audio and tongue stimulation are configured and calibrated to your individual characteristics
during the initial fitting procedure by a trained clinician.
Chapter 2 - Intended use
The Lenire device is intended to be used by tinnitus sufferers of at least 18 years of age to
alleviate the symptoms of chronic, subjective tinnitus. It should be used for 30 to 60 minutes
per day, every day, for at least 10 weeks, after which you may experience sustained alleviation
of your tinnitus symptoms.
The Lenire device can be used in the home environment after consultation and fitting
by a suitably qualified clinician.
Lenire is intended for prescription use only. Use by a person for whom the device has not
been configured may cause discomfort, or temporary exacerbation of tinnitus loudness.
Chapter 3 - Contraindications
Caution! – Do not use the device if:
• You have a pacemaker, defibrillator or any other active implantable device,
unless directed by a doctor.
• You are pregnant, unless directed by a doctor.
• You suffer from epilepsy or any other condition that may result in loss of consciousness.
• You suffer from any condition that causes impaired sensitivity of the tongue.
• You have lesions, sores, or inflammation of the oral cavity, unless directed by a doctor.
Chapter 4 - Risks associated with use
Potential risks associated with use of the Lenire device include
Contact between the Tonguetip and dental retainers or metal fillings may
cause temporary discomfort.
IFU-0026 Lenire User Manual Version 1.0
system,
®
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