Table of Contents
Advertisement
Expected service lifetime
The expected service lifetime for the product when used as intended is:
Product
Hearing aid
Built-in rechargeable battery
Dome
Receivers
Electronic accessories (e.g., wireless accessories)
Non-clinical testing (US only)
The devices covered within this user guide have undergone tests for the relevant non-clinical performance
testing and biological endpoints in accordance with standards identified below:
•
Electrical safety testing is performed according to IEC 60601-1:2005 + A1:2012+A2:2020, IEC 60601-2-
66:2019, IEC 60601-1-11 Edition 2.0 2015-1, IEC 62133-2 Edition 1.0 2017- 02 and IEC 62368-
1:2018/COR1:2020.
•
Electromagnetic compatibility (EMC) testing is performed according to IEC 62479:2010, ANSI IEEE C63.19-
2019 and IEC 60601-1-2:2014+A1:2020.
•
Radio and Telecommunication testing is performed to be in compliance with applicable parts of the FCC rules
in title 47 of the CFR.
•
Electroacoustic testing is performed according to ANSI/ASA S3.22-2014 and ANSI/CTA 2051:2017
Lifetime
5 years
5 years
3 months
2 years
5 years
Regulatory information
65
Advertisement
Table of Contents
