Intended Use; Important Safety Instructions - Pyle PHLHA52 Manual

I. INTRODUCTION
1.1 What is hearing loss?
A speech frequency pure tone average (average of
hearing thresholds at 0.5,1, 2, and 4kHz) of greater
than 25 dB hearing level(HL) in both ears was de ned
as hearing loss per World Health Organization criteria,
and this is the level at which hearing loss begins to
impair communication in daily life. (Extracted from
the literature of: World Health Organization prevention
of Blindness and deafness (PBD) program. Prevention
of Deafness and Hearing Impaired Grades of Hearing
lmpairment)
1.2 What is Digital Hearing Ampli er?
PHLHA52 is a hearing ampli er device that receives
sound and digitize (breaks sound waves up into very
small, discrete units) prior to ampli cation. Unlike
traditional analog hearing ampl er, it simply makes
the sound wave larger to amplify sounds. The most
sophisticated digital hearing aids have built in
intelligence that allows them to discern between soft,
but desirable sounds, and louder with unwanted
noise. Such device can amplify the former, while
neutralizing the latter for better performance in a
variety of environments.
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II. INTENDED USE
2.1 Medical Purpose
The hearing ampli er was intended to compensate of
impaired hearing.
2.2 Intended Patients and Environment
The hearing ampli er are expected to be used indoor
or outdoor environment. Any patients that needs
hearing compensation diagnosed by doctor can use
the PHLHA52 but the patient must be over 36
months of age.
2.3 Side E ects
• Patients with sensitive skin against silicon material,
may cause the ear canal pruritus.
• First use may cause ear canal to have temporary
maladjustment such as slight pain.
III. IMPORTANT SAFETY INSTRUCTIONS
Read all the information in the manual and any other
literature included in the box before using the device.
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