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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 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 according to Annex I of Council Direc-
tive 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.interton.com
• Other identified applicable international regulatory requirements in countries outside the EU. Please
refer to local country requirements for these areas.
• Products are categorized as class 2 receivers according to EN 300 440
