Clinical data (US only)
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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Summary of Contents for ENHANCE SELECT 100 Rx
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