I.NOTICE
II.INTENDED USE
1.1 What is hearing loss?
A speech frequency puretone average
(average of hearing thresholds at 0.5, 1,
2, and 4 kHz) of greater than 25 dB
hearing level (HL) in both ears was
defined 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 Impairment)
1.2 What’s hearing aid?
This hearing aid was used the
air-conduction type to compensate of
impaired hearing. It is a wear sound-am-
plifying device. The fundamental operat-
2.1 Medical purpose
The hearing aid was intended to
compensate of impaired hearing.
2.2 Intended patients and environment
The hearing aid expect used indoor
and outdoor environment, any patients
if need hearing compensated decided
by doctor can be using but the patients
must over than 36 months old.
2.3 Side effects
- For the patients skin sensitive with
silicon material, may be caused the ear
canal pruritus.
02
03
ing principle of hearing aid is to receive,
amplify, and transfer sound to the ear
drum of a hearing impaired person.
