3
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.
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.
• Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is
granted pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Business
Law (電気通信事業法) This device should not be modified (otherwise the granted designation number
will become invalid)
• Patents
US 7,593,537 US 8,00,849
400500011-US-16.07-Rev.A.indd 3 05-07-2016 12:18:35
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