Evidence
The methods and clearances behind every measurement
We don't ask you to take the analysis on faith. Here are the regulatory clearances, the published methodology our metrics implement, and the protocol lineage behind the platform.
K042529 · K070729
FDA 510(k) Clearances
Class II
FDA-Cleared Nystagmograph
Patented Technology
Protected Innovation Since 2004
AIB Methodology
Built upon protocols developed and refined by the American Institute of Balance
Methodology, transparently
Objective Methods. Defensible Results.
balanceback™ is built upon established vestibular testing methodologies and objective eye-movement analysis. Every measurement is designed to provide transparent, traceable clinical data that supports confident interpretation and patient care.
Slow-Phase Velocity (SPV)
Industry-standard objective measurement of nystagmus intensity used throughout clinical videonystagmography.
Jongkees Canal Paresis
Established methodology for quantifying unilateral vestibular weakness and caloric asymmetry.
Caloric Response Analysis
Objective assessment of vestibular response strength using established warm and cool irrigation protocols.
Fixation Index
Quantifies fixation suppression and assists in differentiating peripheral and central findings.
Oculomotor Assessment
Measures saccades, smooth pursuit, optokinetics, and other eye-movement metrics used in vestibular and neurological evaluation.
Traceable Clinical Evidence
Every reported value can be traced back to the underlying eye-movement recording, supporting objective clinical interpretation and defensible reporting.
An honest word on evidence
balanceback is a measurement instrument: it records, displays, and analyzes eye movements. It does not provide a diagnosis — the clinician does. Where we cite reference ranges, they come from established VNG methodology, and full citations are included in the evidence pack. We don't publish accuracy or reproducibility figures without a study on file to back them. What we offer instead is transparency: named methods, the raw trace behind every number, and two decades of cleared clinical use.
FDA-Cleared Class II Nystagmograph · 510(k) K042529 & K070729 · Records, displays & analyzes eye movements — not a diagnosis
Request the full evidence pack
Clearance summaries, the methodology references, and a de-identified sample report — sent to you and ready to share with your team.