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non-invasive  ·  tVNS ·  shipping

Monarch eTNS System

By NeuroSigma

Identity

Manufacturer
NeuroSigma
Model number
—
Codename
—
Aliases
NeuroSigma Monarch, Monarch external Trigeminal Nerve Stimulator
Generation
—
Country of origin
US
Released
Announced
—
Discontinued
—
Status
shipping

Classification

Invasiveness
non-invasive
Modalities
tVNS
Primary modality
tVNS
Direction
write
Categories
clinical-grade, stimulation, therapeutic
Form factor
forehead-patch, handheld
Use cases
paediatric ADHD treatment (FDA-cleared), depression (CE), refractory epilepsy (CE)
Target users
patient-adhd, patient-depression, patient-epilepsy, psychiatrist

Stimulation

Capable
Yes

Connectivity

Protocols
bluetooth-le
Bluetooth
—
Bluetooth profiles
—
Concurrent mode
—
Encryption (transit)
—
Pairing methods
—
Cloud sync
—
Offline recording
—

Power

Sources
non-rechargeable
Battery life (active)
—
Charging port
—
Charging time
—
Battery replaceable
Yes
Notes
Powered by AAA cells.

Physical

Weight
—
Dimensions
—
Materials
—
Sizes
—
Head circumference
—
Operating temp
—

Software & data

Mobile app
Yes
Cloud platform
—
Offline mode
—
Subscription required
Yes
Raw data access
—
Export formats
—
LSL support
No
Data ownership
user
Apps
Monarch eTNS

SDK & developer access

Has SDK
No
Open source
No
Languages
—
Web Bluetooth
No
Raw sample access
No
BCI paradigms
—
3rd-party integrations
—
Docs
—

Regulatory & clinical

FDA status
510k
CE mark
Yes
Certifications
FDA 510(k) K183407 (paediatric ADHD)
Prescription required
Yes
Pediatric approved
Yes

Pricing & availability

MSRP
—
Current price
—
Subscription
—
Warranty
—
Return policy (days)
—
Where to buy
Buy at neurosigma.com

Editor’s take

In favor

  • First FDA-cleared device for paediatric ADHD
  • Non-invasive, home-administered

Against

  • Trigeminal nerve is peripheral — indirect brain modulation
  • Subscription pricing

Sources & provenance

Last reviewed