Recommended Separation Distances for the Earlens Hearing Aid
The Earlens Hearing Aid is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the Earlens Hearing Aid can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
Communications Equipment and the Earlens Hearing Aid as recommended below, according to the
maximum output power of the communications equipment.
Max Output
Separation (m)
Power
150kHz to 80MHz
(Watts)
outside ISM
bands
D=1.2(Sqrt P)
(Test Level 3 V)
0.01
0.12
0.1
0.38
1
1.2
10
3.7
100
12
11.5. FCC Compliance
•
FCC ID: 2AGDU-EL1; IC ID: 20825-EL1
•
The Earlens Light Driven Hearing Aid complies with part 18 of the FCC rules and ICES-003 of the IC
rules.
12. Glossary of Terms
TM
Lens
ELF
EAS
AE
13. Graphic Symbols Contained in Device Labeling
Symbol
Description
Refer to instruction
manual
Separate collection
for electrical and
electronic
equipment
Keep Dry
Separation (m)
Separation (m)
150kHz to
80MHz
in ISM and
Amateur bands
D=2(Sqrt P)
D=1.2(Sqrt P)
(Test Level 6 V)
(Test Level 10
0.2
0.63
2.0
6.3
20
Tympanic Membrane
Tympanic Lens
Earlens Fitting Software
Electronic Article Surveillance
Adverse Event
Reference
Symbol
IEC 60601-
1:2005
ISO 7010-
M002
WEEE
Directive
2012/19/EU,
Annex IX
ISO 15223-
1:2012,
IP21
5.3.4
Separation (m)
80MHz to
800MHz to 2.5GHz
800MHz
D=2.3(Sqrt P)
(Test Level 10 V/m)
V/m)
0.12
0.38
1.2
3.8
12
Description
Temperature limit
Atmospheric
pressure limitation
International
Protection Code
against ingress of
solid foreign objects
≥ 12.5mm diameter
and vertically falling
water drops when
enclosure tilted up to
15°
0.23
0.73
2.3
7.3
23
Reference
ISO 15223-1:2012,
5.3.7
ISO 15223-1:2012,
5.3.9
IEC 60601-1:2005
IEC 60529, 4.2
IFU00022vJ
35