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Usability Engineering was performed in compliance with IEC 62366-1:2015
The devices covered in this user guide passed all tests for the relevant non-clinical performance testing and
biological endpoints, namely cytotoxicity (ISO 10993-05:2009), sensitization, and intracutaneous reactivity (ISO
10993-10:2010).
Similarly, usability testing and software verification and validation demonstrated mitigation of risks to an
acceptable level as well as reasonable assurance of safe and effective device performance.
Clinical data
The devices have been evaluated clinically through equivalence, and the devices have been compared to
equivalent devices and similar devices on the market with similar intended purpose, e.g., to compensate for
hearing impairment by amplifying and transmitting sound to the ear.
Based on technical and clinical data presented for the device in question, the equivalent predecessor and
generally similar devices, it is concluded to support the clinical performance expressed in user needs and claims.
The clinical data leaves no questions open regarding clinical performance and is for this reason deemed
sufficient.
Regulatory information
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