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The products are in compliance with the following regulatory requirements:
•
In the EU: The device conforms to the Essential Requirements according to Annex I of Council Directive
93/42/EEC for medical devices (MDD).
•
GN Hearing A/S hereby declares that the radio equipment types LXR45 are in compliance with Directive
2014/53/EU.
•
The full text of the EU declaration of conformity is available at the following internet address:
www.declarations.resound.com.
•
In the US: FCC CFR 47 Part 15, subpart C.
•
Other identified applicable international regulatory requirements in countries outside the EU and US. Please
refer to local country requirements for these areas.
•
In Canada: these hearing aids are certified under the rules of ISED.
•
Japanese Radio Law and Japanese Telecommunications Business Law Compliance: This device has been
certified pursuant to the Japanese Radio Law (電波 法) and the Japanese Telecommunications Business
Law (電 気通 信事 業 法). This device should not be modified (otherwise the granted designation number will
become invalid).
Type designations
Hearing aid type designations for models included in this user guide are:
LXR45, FCC ID: X26LXR45, IC: 6941C-LXR45.
This device includes an RF transmitter which operates in the frequency band of 2.4 GHz – 2.48 GHz.
Regulatory information
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