De Novo · Ear Nose & Throat

Tyto Insights for Eardrum Bulging Detection

by Tyto Care , Ltd.

Tyto Insights for Eardrum Bulging Detection is an AI-enabled medical device from Tyto Care , Ltd. that the U.S. FDA granted through De Novo DEN250014 on March 17, 2026. Its lead review panel is Ear Nose & Throat and its primary product code is SHL (Ear, Nose, And Throat Image Analyzer).

See also all FDA AI clearances in 2026.

Key facts

Submission numberDEN250014
PathwayDe Novo
Date of final decision
Company (FDA list)Tyto Care , Ltd.
Lead review panelEar Nose & Throat
Primary product codeSHL — Ear, Nose, And Throat Image Analyzer
Applicant (openFDA)Tyto Care , Ltd.
Applicant locationNetanya, IL
Device classClass 2
Regulation number21 CFR 874.4775
Decision codeDENG
Submission typeDirect

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

De Novo is the pathway for novel low-to-moderate-risk devices with no predicate. A granted De Novo creates a new device classification that later devices can use as a predicate. Tyto Insights for Eardrum Bulging Detection went through this pathway (DEN250014).

openFDA lists it as a Class 2 device under 21 CFR 874.4775. Class II devices are moderate risk and are subject to general and special controls.

Product code SHL covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Tyto Care , Ltd. has 7 AI-enabled devices on the list, and the Ear Nose & Throat panel accounts for 1 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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