WAVi Scan System (EEG / ERP)

Clearance & Indications

Cleared to aid in diagnosis. We say exactly that, nothing more.

WAVi captures and analyzes brain electrical activity. The clinician interprets it. We hold the claims to the cleared indication, and BMTG adds the neurologist read so you do not have to.

FDA 510(k) Clearance

WAVi Co, Inc. · Class II medical device

510(k) cleared

FDA 510(k) record

K213900 · WAVi SCAN EEG System and Accessories. Product code GWQ, regulation 21 CFR 882.1400 (electroencephalograph). Cleared May 2022.
View FDA 510(k) record → · Cleared 510(k) summary (PDF)

Indications for use (verbatim)

"The WAVi Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired. WAVi SCAN software is intended for the acquisition, display, and storage of electrical activity of a patient's brain including electroencephalograph (EEG) and event-related potentials (ERP) to aid in diagnosis."

Source: WAVi Regulatory Update →

What WAVi measures

EEG · resting brain wave activity, awake and drowsy
ERP / P300 · event-related potentials, a marker of cognitive processing
QEEG · quantitative analysis against a normative database

Reimbursement

Billable, payer-dependent, documented

When medically necessary $600 to $800 per comprehensive assessment. Typical from TITN aggregated EOB data. Varies by payer, plan, and locality.

Reimbursable CPT codes

95999 · Unlisted neurological procedure for an EEG plus ERP panel device, billed as one unit and not unbundled to component codes; unlisted codes are priced by report and confirmed with the payer before service
99483 · Cognitive assessment and care plan visit (directional Medicare $260 to $282, typically once per 180 days; confirm current rate in the CMS PFS tool)
Component codes (95816 routine EEG, 95957 digital EEG analysis, 95930 VEP) · only where a separate test is independently performed, documented, and payer-recognized

Reference rates per the CMS Physician Fee Schedule. Verify your locality with the CMS PFS Look-Up. Coverage and reimbursement vary by payer.

What TITN claims: WAVi captures EEG and ERP data to aid the clinician in diagnosis. Reimbursable under the listed CPT codes when documentation supports medical necessity.

What TITN does not claim: WAVi does not diagnose Alzheimer's, dementia, concussion, or TBI as a standalone test, and does not treat any condition. Interpretation is the clinician's. The earlier K162460 Research EEG Desktop variant (subject to a 2023 Class 2 recall) is not the cleared system TITN places; the device on this page is K213900.

Clinical Use

One scan, many clinical questions.

Where an objective brain baseline helps the conversation with your patient. Each of these is an aid to your clinical judgment, captured the same way every time so the retest is a true comparison.

Cognitive screening

An objective brain baseline for cognitive health, supporting earlier conversations and longitudinal tracking. Aid in diagnosis, not a standalone diagnosis.

Concussion baseline

Capture a brain baseline before the season, then compare after an event. Objective data for return-to-play conversations, interpreted by your clinician.

ADHD assessment

EEG and ERP markers add objective context to attention evaluations, alongside the published theta/beta ratio literature (Arns et al., 2013 meta-analysis). An aid to evaluation, not a standalone test.

Longitudinal monitoring

The same protocol at intervals turns "I think I feel sharper" into a side-by-side trend the patient and payer can see.

MCI screening support

Pairs with TM-Flow autonomic data in a BMTG MCI Report for functional, longevity, and geriatric cognitive screening. Reimbursable clinical track.

Treatment validation

Run WAVi before and after a therapeutic protocol (ALTMS, photobiomodulation, others) to document objective change, not impressions.

How the Scan Works

Headset on. Twenty minutes. A report read for you.

A trained tech runs it, not the physician. Consistent placement and protocol are what make the retest a real comparison.

01

Headset placement

Rapid placement of multiple EEG electrodes in a routine clinical setting. Comfortable, gel-free saline sensors, no gel mess for the patient.

02

EEG + ERP capture

Resting EEG awake and drowsy, plus event-related potentials including the P300 cognitive-processing marker. Recorded the same way every visit.

03

QEEG analysis

Quantitative analysis against a normative database surfaces the patterns worth a clinician's attention.

04

Report on the portal

Results return on TITN's HIPAA-compliant portal with template visuals, interpreted through BMTG. You get a read, not a raw waveform.

BMTG Interpretation

The neurologist read, on the right report.

Every WAVi scan can come back interpreted. BMTG, TITN's sister service, delivers two distinct reports so the right neurologist signs the right deliverable. You stay in your specialty.

For doctors · MCI Report

Clinical reads on WAVi, on our HIPAA portal.

WAVi scans (with TM-Flow autonomic data where used) come back through TITN's HIPAA-compliant portal with our template visuals and wording. Interpreted by a BMTG team neurologist, or by your own neurologist using our templates. For functional, longevity, and cognitive-screening use.

Reimbursable through standard clinical CPT codes
BMTG Case Reviews for complex presentations
Standard turnaround inside 7 business days

MCI Report details →

For PI attorneys · TBI Report

Objective TBI Reports, signed by a board-certified neurologist.

WAVi-only TBI Reports signed by a board-certified neurologist. Objective biomarker evidence for traumatic brain injury and personal-injury cases. Cash-pay or lien-based depending on case structure.

Quantified EEG / ERP findings, written for the legal record
Available as a standalone deliverable, no device purchase needed
Delivered to the ordering provider, the referring clinic that holds the patient relationship

TBI Report for attorneys →

Specialty Fit

Who reaches for WAVi.

The objective brain baseline fits more practices than most physicians expect. Where it lands first:

Neurology Sports + Concussion Integrative + Functional Geriatrics + Longevity Psychiatry + ADHD Rehab PI Law · via BMTG TBI Report

See It + Pair It

Watch the scan, then build the full picture.

See a co-branded sample report →

Common questions

WAVi, answered.

The questions physicians ask before they order the first scan.

Is WAVi FDA cleared, and what does the clearance cover?

Yes. WAVi is an FDA 510(k) cleared EEG and event-related-potential assessment system (K213900). It is cleared to aid in diagnosis, not to serve as a standalone diagnostic test.

What CPT codes apply, and is it reimbursable?

When medically necessary, the workup typically maps to CPT 95999 and 99483. Reported reimbursement runs about $600 to $800, typical from EOB data and varying by payer, plan, and locality. CMS allows 99483 once per 180 days per patient.

How long does a scan take, and who reads it?

About twenty minutes with the headset on. A board-certified neurologist interprets the data and signs the report through BMTG. Credentials are on file, available on request.

Can WAVi track change over time?

Yes. Because every scan is quantified, a baseline and a retest compare objectively, for example before and after a course of treatment.

Can a WAVi report support a medical-legal case?

Downstream, yes. When a provider orders WAVi and shares the report with counsel, BMTG can produce objective neurodiagnostic documentation signed by a board-certified neurologist. Admissibility is ultimately the court's determination.

Sources & verification Every clearance, code, and figure on this page traces to a live source. View the sources

Verified live June 9, 2026. Spot a broken or outdated link? Email roberto@transitionitnow.com.

FDA & regulatory

FDA 510(k) record K213900 · WAVi SCAN EEG System, product code GWQ, Class II, 21 CFR 882.1400, decision May 6, 2022
K213900 cleared 510(k) summary (PDF) · verbatim indications for use
WAVi Regulatory Update · verbatim indications + K162460 Research EEG Desktop background
FDA recall record, WAVi Research EEG Desktop System (K162460) · Class 2 recall, 2023

CMS reimbursement

CPT 95999 is an unlisted neurological procedure, priced by report at the contractor's discretion; the EEG plus ERP panel is billed as one unit, not unbundled to component codes, and confirmed with the payer before service
CMS Physician Fee Schedule Look-Up · verify 99483 (cognitive assessment and care plan visit) and any separately performed component codes for your locality
99483 Medicare payment is directional ($260 to $282); confirm the current-year national amount in the CMS PFS tool above. Range varies by payer, plan, and locality.
Reimbursement range ($600 to $800 per assessment) is directional, from TITN aggregated EOB billing data; not a guarantee of payment, and varies by payer, plan, and locality.

Peer-reviewed clinical context

Polich J. (2007) · Updating P300: an integrative theory of P3a and P3b. Clinical Neurophysiology. (Foundational ERP reference, not WAVi-specific.)
Arns M, Conners CK, Kraemer HC. (2013) · A decade of EEG theta/beta ratio research in ADHD: a meta-analysis. J Atten Disord.

Manufacturer documentation

WAVi research index · manufacturer-curated white papers, publications, and case studies
WAVi Scan Manual / IFU (PDF)

WAVi Scan System