Data / Federal rules / 2026-11589

Medical Devices; Ear, Nose, and Throat Devices; Classification of the Combined Acoustic and Electrical External Stimulation Device for the Relief of Tinnitus

The Food and Drug Administration published this final rule in the Federal Register on June 10, 2026. It took effect on June 10, 2026.

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What the agency says

The Food and Drug Administration (FDA) is classifying the combined acoustic and electrical external stimulation device for the relief of tinnitus into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the combined acoustic and electrical external stimulation device for the relief of tinnitus. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Key facts

Document number: 2026-11589
Type: Final rule
Action: Final amendment; final order
Agency: Health and Human Services Department; Food and Drug Administration
Published: June 10, 2026
Takes effect: June 10, 2026
Dates: This order is effective June 10, 2026. The classification was applicable on March 6, 2023.
Docket: Docket No. FDA-2026-N-6010
Code of Federal Regulations: 21 CFR 874
Topics: Medical devices
Pages: 3

The document on federalregister.gov PDF

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Everything from the Food and Drug Administration · Rules on medical devices · Published in June 2026

Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.