
1716
Important notice for prospective hearing
instrument users (FDA required statement)
Good health practice requires that a person with a hearing
loss have a medical evaluation by a physician (preferably
a physician who specializes in diseases of the ear) before
purchasing a hearing instrument. Licensed physicians who
specialize in diseases of the ear are often referred to as
otolaryngologist, otologists or otorhinolaryngologists. The
purpose of medical evaluation is to assure that all medically
treatable conditions that may affect hearing are identied
and treated before the hearing instrument is purchased.
Allergies
The materials used in making your hearing instrument are
of the highest quality available. The likelihood of an allergic
reaction is slight. If an allergic reaction should occur, it
may take the form of skin irritation. If a reaction occurs, we
strongly suggest that you discontinue use and contact your
physician.
inquiry, actual observation, or review of any other available
information concerning the prospective user, that the
prospective user has any of the following conditions:
1. Visible congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the
previous 90 days.
3. History of sudden or rapidly progressive hearing loss
within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within
the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15
decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
7. Visible evidence of signicant cerumen accumulation or
a foreign body in the ear canal.
8. Pain or discomfort in the ear.
Children
In addition to seeing a physician for a medical evaluation, a
child with a hearing loss should be directed to an Audiologist
for evaluation and rehabilitation. Hearing loss may cause
problems in speech and language development and the
educational and social growth of the child.
Message to Dispenser (FDA required statement)
A hearing instrument dispenser should advise a prospective
hearing instrument user to consult promptly with a licensed
physician (preferably an ear Specialist) before dispensing
a hearing instrument if the dispenser determines through
Specications (ANSI S3.22-2003):
Peak OSPL90 Range 105*
HFA OSPL90 Range 100*
HFA/FOG-dB Range 32
RTG-dB Range 23
Battery Drain Range-mA 0.85
Frequency Range 200-6.5KHz
Distortion <3%
EQ Input Noise Level <28dB
Attack/Release Time-mS 8/400
*AGC not fully activated