Alert detail
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
What changed
Final Rule published 2026-06-01. The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator 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 oropharyngeal electrical stimulator. We are taking this action because we have determined that classifying the device into c
Who’s affected: Multi-specialty billing teams · Effective: June 1, 2026
Primary source: View the official CMS/MAC document ↗
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