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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.
What is in the box?
The following items are included in the package:
•
A set of 2 hearing aids
•
Extra batteries, type 312
•
A "clamshell" storage case
•
Extra domes. See "Changing your hearing aid domes", page 32
•
A cleaning cloth and brush. See "Cleaning tools", page 30
•
A wax guard kit. See "Changing the wax filter", page 36
•
An ear measuring tool for receiver wires. See "Replacing the receivers", page 39
•
A tool for receiver wire replacement. See "Replacing the receivers", page 39
•
A kit of cards to get you started
8
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