US device clearances
2 510(k) clearances and PMA approvals since 2015
- Tuned Self-Fitting Mobile App K251208 · 26 Sep 2025
- Intrisound™ Tuned Lumen® 155 Hearing Aids K223848 · 8 Sep 2023
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.