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
