User Manual

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Intended use
Hearing Instruments are intended for hearing impaired people to improve their hearing. The es-
sential purpose of the hearing instruments is to receive, amplify and transfer sound to the ear
drum of a person with hearing loss.
List of countries:
Products without wireless functionality are intended for worldwide sales.
Products with wireless functionality are intended for sale in countries within the European Eco-
nomic Area as well as Switzerland.
Specification of restrictions: You are not allowed to operate the equipment within 20 km of the
centre of Ny Ålesund, Norway.
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) and essential requirements and other rel-
evant provisions of Directive 1999/5/EC (R&TTE). The declaration of conformity may be con-
sulted at www.resound.com
• In US: FCC CFR 47 Part 15, subpart C, section 15.249.
• Other identified applicable international regulatory requirements in countries outside the EU
and US. Please refer to local country requirements for these areas.
• Products are categorized as class 2 receivers according to EN 300 440