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The products are in compliance with the following regulatory requirements:
• In 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 declares that the radio equipment type(s) LO85 and LO90 is/are in compliance with
Directive 2014/53/EU (RED).
• The declaration of conformity may be consulted at www.declarations.resound.com/
• In 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 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
This device operates in the frequency range of 2.4 GHz - 2.48 GHz.
This device includes an RF transmitter that operates in the range of 2.4 GHz - 2.48 GHz.
Maximum RF output power transmitted is up to 0 dBm.
Intended use
Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to compen-
sate for impaired hearing. The fundamental operating principle of hearing instruments is to receive, amplify,
and transfer sound to the ear drum of a hearing impaired person.
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