Regulatory and legal information
112
11
Expected Service Life of Product and Components:
2 Years
Classication: The hearing aids are classied as a
Type B Applied Part, IEC 60601-2-66
b
Lexie B2 Hearing Aids, Powered by Bose comply with
the following domestic and international regulations
for medical devices:
IEC 60601-1:2005/A1:2012
IEC 60601-1-2:2014
IEC 60601-2-66:2019
IEC 60601-1-6:2010
FCC 47 Part 15.247
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