Regulatory Information | 37
36 | Regulatory Information
Safety Information
INTENDED USE:
An air conduction hearing aid is a wearable sound-
amplifying device intended to compensate for impaired hearing. Hearing
aids are available in multiple gain/output levels appropriate to treat hearing
losses ranging from mild-to-profound.
Your hearing aids are designed to operate in public and residential
environments and are designed to comply with international Electromagnetic
Compatibility emissions and immunity standards for medical devices.
However, it is still possible that you may experience interference caused by
power line disturbances, airport metal detectors, electromagnetic fields from
other medical devices, radio signals and electrostatic discharges.
If you use other medical devices or wear implantable medical devices such as
defibrillators or pacemakers and are concerned that your hearing aids might
cause interference with your medical device, please contact your physician or
the manufacturer of your medical device for information about the risk of
disturbance.
Your hearing aids should not be worn during an MRI procedure or in a
hyperbaric chamber.
Your hearing aids are classified as a Type B applied part under the IEC
60601-1 medical device standard.
Your hearing aids are not fully certified to operate in explosive atmospheres
such as may be found in coal mines or certain chemical factories.
Your hearing aids should be stored within the temperature and humidity
ranges of -40°C (-40°F) to +60°C (140°F) and 10%-95% relative humidity.
Your hearing aids are designed to operate beyond the range of temperatures
comfortable to you, from very cold up to 50°C (122°F).
Use on Aircrafts
The wireless capabilities that may be featured in your hearing aids can be
used on an aircraft as hearing aids are exempt from the rules applied to other
personal electronic devices on an aircraft. Your smartphone device should be
put into
Airplane Mode
or turned off.
International Use
Your hearing aids are approved to operate at a radio frequency that is specific
to your country or region and might not be approved for use outside your
country or region. Be aware that operation during international travel may cause
interference to other electronic instruments, or other electronic instruments may
cause interference to your hearing aids.
We are required by regulations to provide the following warnings:
WARNING:
Use of wireless hearing aids directly next to other electronic
equipment should be avoided because it could result in improper performance.
If such use is necessary, note as to whether your hearing aids and the other
equipment are operating normally.
WARNING:
Use of accessories, components or replacement parts other than
those provided by the manufacturer of your hearing aids could result in increased
electromagnetic emissions and decreased electromagnetic immunity and could
result in degradation of performance.
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.
Required Hearing Aid Information
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.