IFU-0002 Lenire User Manual Version 1.0Page 4
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 suerers 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.
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