Regulatory Information | 49 48 | Regulatory Information
WARNING: If Portable Radio Frequency communications
equipment is used closer than 30 cm (12 inches) from your
hearing aid, degradation of the performance of your hearing aid
could result. If this occurs, move away from the communications
equipment.
WARNING: The stability of the hearing aid is designed
for normal use. Avoid physical impacts to the ear when wearing
a hearing aid that may cause the device to break or component
of the device to become detached. This may lead to lacerations
of the ear canal or perforation of the ear drum. If this occurs, it is
strongly recommended to see a physician for evaluation and safe
removal.
WARNING: If the hearing aid drops onto a hard surface,
it could cause the hearing aid to break or become damaged.
This includes mechanical stress or shock of the device. Ensure
the hearing aid is intact before placing it in the ear. If you find
the device is damaged, discontinue use and see your hearing
professional.
WARNING: Repeated stress to the removal handle may
cause it to break. If the removal handle breaks and you’re unable
to remove the device carefully, it is recommended to see a
physician for safe removal.
Do not open hearing aid OR CHARGER,
no user-serviceable parts inside
The Starkey Charger has a rating of IP 5X per IEC 60529. This
means that the Starkey Laboratories, Inc. Charger is protected
from dust.
The following additional information is provided in compliance
with U.S. Food and Drug Administration (FDA) regulations:
WARNING TO HEARING AID DISPENSERS
A hearing aid dispenser should advise a prospective hearing aid
user to consult promptly with a licensed physician (preferably
an ear specialist) before dispensing a hearing aid if the hearing
aid dispenser determines through inquiry, actual observation
or review of any other available information concerning the
prospective user that the prospective user has any of the following
conditions:
i. Visible congenital or traumatic deformity of the ear.
ii. History of active drainage from the ear within the
previous 90 days.
iii. History of sudden or rapidly progressive hearing
loss within the previous 90 days.
iv. Acute or chronic dizziness.
v. Unilateral hearing loss of sudden or recent onset
within the previous 90 days.
vi. Audiometric air-bone gap equal to or greater than
15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz.
vii. Visible evidence of significant cerumen accumulation
or a foreign body in the ear canal.
viii. Pain or discomfort in the ear.
IMPORTANT NOTICE FOR PROSPECTIVE
HEARING AID USERS
Good health practice requires that a person with a hearing loss
have a medical evaluation by a licensed physician (preferably a
physician who specializes in diseases of the ear) before purchasing
a hearing aid. Licensed physicians who specialize in diseases of
the ear are often referred to as otolaryngologists, otologists or
otorhynolaringologists. The purpose of the medical evaluation is
to assure that all medically treatable conditions that may affect
hearing are identified and treated before the hearing aid is
purchased.
Following the medical evaluation, the physician will give you a
written statement that states that your hearing loss has been
medically evaluated and that you may be considered a candidate
for a hearing aid.
The physician will refer you to an audiologist or hearing aid
dispenser, as appropriate, for a hearing aid evaluation.
The audiologist or hearing aid dispenser will conduct a hearing aid
evaluation to assess your ability to hear with and without a hearing
aid. The hearing aid evaluation will enable the audiologist or
dispenser to select and fit a hearing aid to your individual needs.
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