IFU-0002 Lenire User Manual Version 1.0Page 6
Chapter 4 - Risks Associated with Use
Potential risks associated with use of the Lenire device include:
Chapter 5 - General Warnings
Contact between the tonguetip and dental retainers or
metal fillings may cause temporary discomfort.
There is a possibility that some people may experience
a mild allergic reaction to the materials in the device.
You may experience a mild numbing sensation or
a discomfort on the tongue during treatment. If this
occurs, reduce the tongue stimulation. If the symptoms
persist, contact your clinician.
Use of the treatment may result in mild fluctuations in
tinnitus symptoms, such as tinnitus loudness.
Headaches may accompany use of the treatment
device.
Do not use the tonguetip when going to sleep or under
the influence of alcohol or other substances that cause
drowsiness.
Keep the tonguetip and Charger out of the reach of
children, to avoid possible choking and strangulation
hazards.
To avoid the risk of cross-contamination, the tonguetip
should not be shared with any other person, as it is a
single-patient, multi-use device.
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