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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 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
• In US: FCC CFR 47 Part 15, subpart C, section 15.249.
• Other identified applicable international regulatory requirements in countries outside the EU
and US. Please refer to local country requirements for these areas.
• Products are categorized as class 2 receiver according to EN 300 440
• In Canada these hearing instruments are certified under models: PH312/IC: 6941C-PH312,
BO13/IC: 6941C-BO13, BO312/IC: 6941C-BO312, PH13/IC: 6941C-PH13.
• This Class B digital apparatus complies with Canadian ICES-003.
17483400-GB-12.02-Rev.H.indd 5 24-02-2012 09:29:45