Name: ReSound OMNIA
Brand: ReSound
Rating: 4 (1 reviews)

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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.

Regulatory information 53

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ReSound OMNIA Specifications

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