Range
Center Frequency
Channel
Bandwidth
Data-Rate
Data Flow
Protocol
S.A.R.*
* Specific Absorption Rating (S.A.R.) for continuous transmission
(100% duty cycle) based on 10g ICNIRP testing.
EMI/EMC COMPLIANCE
Wireless hearing aids comply with the following EMC/EMI standards:
Standard
47 CFR Part 15,
RF emissions
Subpart C
EN 300 330-1/2
RF emissions
including
spurious
emission
IEC 60601-1-2
EMC emission
immunity, RF
and ESD
EN 301 489-1/3
Immunity, RF
and ESD
IEC 60118-13
Immunity
RF near field
immunity test
ANSI C63.19
Immunity
RF near field
immunity test
ANSI/AAMI
EMC immunity
PC69:2007
EN 45502-2-1
EMC immunity
WIRELESS SECURITY MEASURES
Wireless signal security is assured through device system design
that includes:
Wireless Hearing Aids (continued)
<1 m remote to hearing aid
<30 cm between aids or aid to remote
3.28 MHz
Single Channel Radio
67 kHz
655 kbit/sec (raw channel capacity)
Simplex or semi-duplex capability
Random access – no collision avoidance
5 nW/kg (BTE), 13 nW/kg (ITE)
Test Type
U.S. FCC requirements for intentional radiators.
EMC and radio spectrum matters for short range
devices in the frequency range 9 kHz – 25 MHz.
Medical electrical equipment. General
requirements for basic safety and essential
performance. Electromagnetic compatibility.
Standard for low power transmitters in the
frequency range 9 kHz – 40 GHz.
International product standard for hearing
aids to ensure adequate immunity to radio
interference from mobile telephones.
American National Standard method of
measurement of compatibility between wireless
communication devices and hearing aids.
Implantable medical device EMC immunity.
Particular requirements for pacemakers.
Note
21