Ear Nose & Throat · De Novo · 2026
Tyto Insights for Eardrum Bulging Detection
Tyto Care , Ltd.. Granted by FDA on 17 March 2026 under submission DEN250014, product code SHL (ear, nose, and throat image analyzer). What FDA's record says, in FDA's words.
Device record · DEN250014
- Device. Tyto Insights for Eardrum Bulging DetectionDEVICE
- Company. Tyto Care , Ltd.COMPANY
- Decision. 17 March 2026, De NovoDECISION
- Panel. Ear Nose & ThroatPANEL
- Product code. SHL, Ear, Nose, And Throat Image AnalyzerCODE
- Regulation. 21 CFR 874.4775, Class IIREG
- Source. FDA database entry · decision document (16 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA granted it for
The Indications for Use statement, verbatim, from the decision document.
. (2) Human factors/usability testing must demonstrate that the user can correctly use the device, based solely on reading the directions for use. (3) Software verification, validation, and hazard analysis must be performed. (4) Labeling must include: (i) Hardware compatibility information; (ii) A warning that the device is not intended to be used independently for diagnosis; and (iii) A summary of the clinical performance testing conducted with the device, including the study endpoints and statistical confidence intervals. B ENEFIT-RISK DETERMINATION The probable benefits of this device are to automatically detect eardrum bulging in Otoscopic video recordings (which would otherwise be detected visually, relying on clinical experience and judgment to interpret the tympanic membrane position and characte ristics). Bulging is a medical characteristic of the tympanic membrane that is commonly used for the diagnosis of Acute Otitis Media, but is also observed in ear trauma, barotrauma, bullous myringitis, etc. Therefore, the device can provide an aid to diagnosis when used in conjunction with otoscopic ear examinations and when considering all patient symptoms and medical history. There is a risk of inappropriate patient management in the setting of inaccurate output from the device, which can lead to either incorrect, unnecessary, or delayed patient treatment/medication. However, labeling can mitigate these risks such as by including a warning reminding the lay user not to […]
The product code's definition, from FDA's classification record. An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SHL. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SHL, in Ear Nose & Throat, from Tyto Care , Ltd., or granted in 2026. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.