FDA-cleared AI ear nose & throat devices
The FDA's AI-enabled device list has 1 devices whose lead review panel is Ear Nose & Throat, 0.1% of all 1,614 listed devices. They come from 1 companies. The first decision was on March 17, 2026 and the most recent on March 17, 2026.
1AI devices
1Companies
2026First decision
2026-03-17Latest decision
Trend: devices per year
2026
Top companies
Most common product codes
All 1 devices, newest first
Frequently asked questions
How many FDA-cleared AI ear nose & throat devices are there?
As of the FDA list updated through June 29, 2026, 1 AI-enabled devices have Ear Nose & Throat as their lead review panel (0.1% of the list).
Which companies have the most AI ear nose & throat devices?
Tyto Care , Ltd. (1) have the most AI-enabled ear nose & throat devices on the FDA list.
Which year had the most AI ear nose & throat authorizations?
2026 had the most, with 1 device.
Which FDA pathways are used for AI ear nose & throat devices?
De Novo: 1.
What was the most recent AI ear nose & throat device on the list?
Tyto Insights for Eardrum Bulging Detection from Tyto Care , Ltd. (DEN250014), with a decision dated March 17, 2026.