ReSound OMNIA - Page 53

The products are in compliance with the following regulatory requirements:
• In EU: The device conforms to the General Safety and Performance Requirements according to AnnexI of
the EU Medical Device Regulation 2017/745 (MDR).
• Hereby, GN ReSound A/S declares that the radio equipment type CAIR1L and CAIR1R is in compliance with
Radio Equipment Directive 2014/53/EU (RED).
• 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.
• 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).
• For other international regulatory requirements, please refer to the regulatory requirements of the specific
country.
Type designations
Hearing aid type designations for models included in this user guide are:
CAIR1: CAIR1R (Right), FCC ID: X26CAIR1R, IC: 6941C-CAIR1R; CAIR1L (Left), FCC ID: X26CAIR1L, IC:
6941C-CAIR1L.
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