Regulatory Information | 49
48 | Regulatory Information
CAUTION:
If set to the maximum output level and worn for periods of time
exceeding the recommendations below, your exposure to sound energy has the
potential to exceed noise exposure limits. You should not use your hearing aid
for more than sixteen (16) hours a day if your hearing aid is set at the maximum
output level, nor should you use your hearing aid if your hearing professional
has set the hearing aid at levels that exceed your comfort level.
Important Notice for Prospective
Sound Generator Users
Good health practice requires that a person with tinnitus have a medical
evaluation by a licensed physician (preferably a physician who specializes in
diseases of the ear) before using a sound generator. Licensed physicians who
specialize in diseases of the ear are often referred to as otolaryngologists,
otologists or otorhinolaryngologists.
The purpose of a medical evaluation is to assure that all medically treatable
conditions that may affect tinnitus are identified and treated before the sound
generator instrument is used.
TINNITUS TECHNICAL DATA
Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when
measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
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 -13 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:
• IEC 60601-1-2 radiated emissions requirements for a Group 1 Class B device as
stated in CISPR 11.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz
as well as higher field levels from communications devices as stated in Table 9
of IEC 60601-1-2.
• Immunity to power frequency magnetic fields at a field level of 30 A/m.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV
air discharge.
The Starkey Hearing Technologies Charger has been tested to, and has passed,
the following emissions and immunity tests:
• IEC 60601-1-2 radiated and conducted emissions requirements for a Group 1
Class B device as stated in CISPR 11.
• Harmonic distortion and voltage fluctuations affecting the power input source
as stated in Table 2 of IEC 60601-1-2.
• RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz
as well as higher field levels from communications devices as stated in Table 9
of IEC 60601-1-2.
• Immunity to power frequency magnetic fields at a field level of 30 A/m.
• Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air
discharge.
• Immunity to Electrical fast transients on the power input at a level of +/- 2 kV
at a 100 Hz repetition rate.
• Immunity to Surges on the power input of +/- 1 kV line to line.
• Immunity to conducted disturbances induced by RF fields on the power input
as stated in Table 6 of IEC 60601-1-2.
• Immunity to voltage dips and interruptions on the power input as stated in
Table 6 of IEC 60601-1-2.
WIRELESS NOTICES
FCC ID: EOA-24LIVIOBCHG
IC: 6903A-24LIVIOBCHG
FCC NOTICE
This hearing aid and Starkey Hearing Technologies Charger complies
with part 15 of the FCC rules and with ISED Canada license-exempt RSS
standards. Operation is subject to the following two conditions: (1) This device
may not cause harmful interference, and (2) this device must accept any
interference received, including interference that may cause undesired operation
of the device.
Note: The manufacturer is not responsible for any radio or TV interference caused
by unauthorized modifications to this equipment. Such modifications could void
the user’s authority to operate the equipment.
EU NOTICE
Hereby, Starkey Hearing Technologies declares that the rechargeable BTE is
in compliance with the essential requirements and other relevant provisions of
Directive 2014/53/EU. A copy of the Declaration of Conformity can be obtained
from the address below or from docs.starkey hearingtechnologies.com