ReSound Receiver-in-ear Hearing Instrument User Manual page 3

intended use
Hearing Instruments are intended for hearing impaired people to improve their hearing. The essential
performance of Hearing Instruments is to receive, amplify and transfer sound to the ear drum of a
hearing impaired person.
List of countries:
Products without wireless functionality are intended for worldwide sales.
Products with wireless functionality are intended for sale in countries within European Economic
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.
4
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 Direc­
tive 93/42/EEC for medical devices (MDD) and essential requirements and other relevant provi­
sions of Directive 1999/5/EC (R&TTE).
The declaration of conformity may be consulted 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 EU and US.
Please refer to local country requirements for these areas.
• Products are categorized as class 2 receiver according to EN 300 440
5