# K243709: NeuroEars-Anna™

- Pathway: 510(k) (Traditional)
- Applicant: Neuroears, Inc.
- Decided: Aug 25, 2025 after 266 days
- Product code: GWN (Nystagmograph)
- Device class: 2
- Regulation: 21 CFR 882.1460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K083603 (2009). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143607: I-Portal NOTC, VNG and VOG, Neuro Kinetics, Inc. (2015) Summary page 6.

## Indications for use
The NeuroEars-Anna™ system provides information to assist in the nystagmographic evaluation, diagnosis, and documentation of vestibular disorders. Nystagmus of the eye is recorded using a head-mounted display equipped with eye-tracking cameras. These images are measured, recorded, displayed, and stored in the software. This information can then be used by trained medical professionals to assist in diagnosing vestibular disorders. The NeuroEars-Anna™ system is intended for use in individuals aged 12 years and older, based on the physical compatibility of the FOVE VR headset (FOVE Inc., Japan). While the ANSI S3.45 standard does not define age-based limitations, the FOVE VR headset is generally suitable for individuals aged 12 and above. For improved fit, soft materials such as sponge pads may be used in cases where the headset does not conform properly to the user's face. This applies to both pediatric and adult patients. Any additional padding should be used only if it does not interfere with eye-tracking performance or measurement accuracy and must follow the manufacturer’s instructions for proper use.

Source page: https://510kreport.com/device/K243709
Methodology: https://510kreport.com/methodology