Otoharmonics Levo System

FDA-cleared tinnitus masking software and customized sound-therapy system intended to generate patient-specific sounds for temporary relief of tinnitus symptoms within a tinnitus management program.

Verified as a real FDA-cleared historical tinnitus software/device record. Current commercial availability and ownership are still not confidently established because the former Otoharmonics domain is repurposed, so the record should remain Tier 3 with current status unknown rather than being presented as an active product.