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Tuned , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251208Tuned Self-Fitting Mobile AppSeptember 26, 2025
K223848Intrisound™ Tuned Lumen® 155 Hearing AidsSeptember 8, 2023