Intended Use; List Of Countries - ReSound 60 series User Manual

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.

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.
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 relevant provisions of Direc-
tive 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.
• Other identified applicable international regulatory requirements in countries outside EU and US. Please
refer to local country requirements for these areas.
• In Canada: these hearing instruments are certified under the rules of IC.
• Cet appareil numérique de la classe B est conforme à la norme NMB-003 du Canada.
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