The products are in compliance with the following regulatory requirements:
•
T he device conforms to the Essential Requirements according to Annex I of Council Directive
93/42/EEC for medical devices (MDD).
•
Hereby, GN ReSound A/S declares that the radio equipment types BEB80 and LOB90 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 ISED rules.
•
Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This
device is granted 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 designations for models included in this user guide are:
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