Regulatory Information | 51 50 | Regulatory Information
If you have reservations about your ability to adapt to
amplification, you should inquire about the availability of a trial-
rental or purchase-option program. Many hearing aid dispensers
now offer programs that permit you to wear a hearing aid for a
period of time for a nominal fee after which you may decide if you
want to purchase the hearing aid.
Federal law restricts the sale of hearing aids to those individuals
who have obtained a medical evaluation from a licensed
physician. Federal law permits a fully informed adult to sign a
waiver statement declining the medical evaluation for religious or
personal beliefs that preclude consultation with a physician. The
exercise of such a waiver is not in your best health interest and its
use is strongly discouraged.
A hearing aid will not restore normal hearing and will not
prevent or improve a hearing impairment resulting from organic
conditions. Use of a hearing aid is only part of hearing habilitation
and may need to be supplemented by auditory training and
instruction in lip reading. In most cases infrequent use of a hearing
aid does not permit a user to attain full benefit from it. Special care
should be exercised in selecting and fitting a hearing aid whose
maximum sound pressure level exceeds 132 decibels because
there may be risk in impairing the remaining hearing of the hearing
aid user.
Some hearing aid users have reported a buzzing sound in their
hearing aid when they are using mobile phones, indicating that the
mobile phone and hearing aid may not be compatible. According
to the ANSI C63.19 standard (ANSI C63.19-2007 American
National Standard Methods of Measurement of Compatibility
Between Wireless Communications Devices and Hearing Aids), the
compatibility of a particular hearing aid and mobile phone can be
predicted by adding the rating for the hearing aid immunity to the
rating for the mobile phone emissions. For example, the sum of a
hearing aid rating of 2 (M2/T2) and a telephone rating of 3 (M3/
T3) would result in a combined rating that equals at least 5 would
provide “normal use”; a combined rating of 6 or greater would
indicate “excellent performance”. See the Product Card or Quick
Start Guide included with your hearing aid for the exact M/T rating
of your hearing aid.
CHILDREN WITH HEARING LOSS
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 since hearing loss may cause
problems in language development and the educational and
social growth of a child. An audiologist is qualified by training
and experience to assist in the evaluation and rehabilitation of
a child with a hearing loss.
For the Patient
PRESCRIPTION USE ONLY
CAUTION: Federal law restricts this device to sale by
or on the order of a doctor, audiologist or other hearing care
practitioner licensed to dispense hearing aids in your state.
Your hearing professional will also be able to offer the appropriate
follow-up care. It is important that you follow your hearing
professional’s advice and direction regarding such care.
CAUTION: If set to the maximum output level and worn
for periods of time exceeding the following recommendations,
your exposure to sound energy has the potential to exceed noise
exposure limits. You should not use your hearing device for more
than sixteen (16) hours a day if your device is set at the maximum
output level, nor should you use your device if your hearing
professional has set the device at levels that exceed your comfort
level. If, throughout the course of wearing the hearing aid, you
notice a change hearing threshold, please discontinue use and
contact physician.
WIRELESS TECHNICAL DESCRIPTION
Your hearing aids contain a radio transceiver utilizing Bluetooth
Low Energy wireless technology operating in the 2.4-2.4835 GHz
frequency band with a maximum effective radiated power of 0
dBm using GFSK transmission modulation. The receiver section of
the radio has a bandwidth of 1.5 MHz.
This hearing aid model has been tested to, and has passed, the
following emissions and immunity tests:
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