Intended Use; List Of Countries - ReSound Standard Tube User Manual

Intended use

Generic air-conduction hearing instruments are wearable sound-
amplifying devices intended to compensate 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 the 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.
The products are in compliance with the following
regulatory requirements:
In the EU: The device conforms to the Essential Requirements
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according to Annex I of Council Directive 93/42/EEC for medical
devices (MDD) and Essential Requirements and other relevant
provisions of Directive 1999/5/EC (R&TTE). The declaration of
conformity may be consulted at www.resound.com
Other identified applicable international regulatory requirements in
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countries outside the EU. Please refer to local country requirements
for these areas.
Products are categorized as class 2 receivers according
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to EN 300 440
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