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Business · 10/06/2026Updated: 10/17/2026 · 1 min read

FDA Classifies Combined Acoustic and Electrical Stimulation Device for Tinnitus Relief into Class II

Summary

The FDA has classified the combined acoustic and electrical external stimulation device for the relief of tinnitus into Class II, a move aimed at ensuring the device's safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative treatments.

Original source language: Federal Register — Health and Human ServicesOpen original release →

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