Expected service lifetime
The expected service lifetime for the product when used as intended is:
Product Lifetime
Hearing aid 5 years
Built-in rechargeable battery 5 years
Electronic accessories (e.g., wireless accessories) 5 years
Non-clinical testing (USonly)
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
• Usability Engineering was performed in compliance with IEC 62366-1:2015
Regulatory information 53
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