Neuromodulation to treat symptoms associated with PTSD

Modius Spero - available through the VA

Clinically proven to
reduce PTSD symptoms.

The world’s first FDA-authorised, non-invasive neurostimulation device to treat the symptoms of PTSD.

Modius Spero is a home-use device indicated for the treatment of symptoms associated with Post-traumatic Stress Disorder (PTSD), for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional, in adults aged 22 and older.

How does it work
The Modius technology works by activating regions of the brain that control stress response to treat symptoms associated with PTSD. It does this by delivering small and safe electrical pulses to the skin behind each ear. This technology is known as electrical Vestibular System Stimulation (VSS).

What does it feel like?
Modius Spero delivers a small, safe electrical pulse, which may create a mild sensation during use. Many users describe a calming, swaying feeling that promotes relaxation. We recommend you stay seated while the device is active, perhaps reading a magazine, watching television or browsing the internet.

Clinically proven to treat symptoms associated with PTSD

Study findings

A safe and effective treatment

FDA-granted (De Novo) for treating symptoms associated with PTSD insomnia.
Designed for at-home use to improve patient compliance.
Proven therapeutic outcomes through robust clinical trials.
Automatically limits sessions to 30 minutes for patient safety and ease of use.
A strong safety profile with minimal side effects, which can be effectively managed by reducing or discontinuing stimulation as needed.

* Individual results may vary

66%

of trial participants achieved clinically meaningful reduction (≥10 points) in PCL-5 score at 12 weeks.

Important Information

Modius Spero is a home-use device indicated for the treatment of symptoms associated with Post-traumatic Stress Disorder (PTSD), for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional, in adults aged 22 and older.

Intended Use

Modius Spero is a home-use device indicated for the treatment of symptoms associated with Post-traumatic Stress Disorder (PTSD), for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional, in adults aged 22 and older.

Limitations
The sale, distribution, and use of the Modius Spero are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended to be used as a stand-alone therapeutic device.
To mitigate the risk of dizziness, the device must be used when seated. The device is not to be used when driving or operating machinery of any kind.
The safety and effectiveness of Modius Spero for use in people with PTSD symptoms has not been established after twelve weeks of use.

Indications for Use

Modius Spero is a home-use device indicated for the treatment of symptoms associated with Post-traumatic Stress Disorder (PTSD), for use in conjunction with a comprehensive treatment plan under the direction of a healthcare professional, in adults aged 22 and older.

Limitations
The sale, distribution, and use of the Modius Spero are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended to be used as a stand-alone therapeutic device.
To mitigate the risk of dizziness, the device must be used when seated. The device is not to be used when driving or operating machinery of any kind.
The safety and effectiveness of Modius Spero for use in people with PTSD symptoms has not been established after twelve weeks of use.

Contraindications

Modius Spero should not be used if:

• You are under the age of 22
• You are suffering from a skin condition affecting the skin behind the ears (e.g., eczema)
• You have been diagnosed with vestibular or inner ear disease by a physician or clinician
• You have a rare form of epilepsy that is triggered by a problem in your inner ear
• You are pregnant
• You have an implanted pacemaker, cardiac defibrillator or neurostimulation device

Warnings & Precautions

Please read the user manual and make sure that you understand the instructions before you use the product.
Modius users should be monitored by their physician for side effects and signs of symptom worsening.
Modius is not intended as a stand-alone therapy or to alter usual care treatment.
Only place stimulation pads on the skin behind the ears, as directed in the instructions provided. Do not place on your chest or elsewhere on the head or neck.
If an unexpected reaction occurs, discontinue use of Modius immediately.
Only use the stimulation pads specified by the manufacturer for use with this device. Pads not tested with this device may affect safety and performance. Additional Stimulation Pads can be purchased via Neurovalens Support – See Support Section – “How to request repair or support” (page 33).
Keep this product away from children as small items such as stimulation pads are choking hazards.
It is recommended that you use this device only while seated.
Modius must not be used while driving or operating machinery of any kind.
Modius is for adults 22 and older only.
Dispose of stimulation pads in a suitable bin after use.
If you feel any discomfort during a session, pause the session and reduce the stimulation level via the buttons on the deviceuntil it is at a comfortable level before resuming your session.
Possible hazards or side effects include skin irritation; discomfort from the stimulation; sensation of feeling off-balance; dizziness; eye movements (nystagmus); blurred or flashing vision; headache; nausea and persistent ear ringing (tinnitus). Please see page 37 for how often these side effects occurred in the Modius Spero clinical trial. If a problem persists, please consult your physician.
To mitigate the risk of dizziness, the device must be worn when seated and start stimulation at a low level and increase gradually to the highest comfortable level. If you do experience dizziness, discontinue stimulation by turning off the device. If dizziness persists, please consult your physician.
To mitigate the risk of headaches, start stimulation at a low level and increase gradually to the highest comfortable level. If you do experience a headache, discontinue stimulation by turning off the device. If a headache persists, please consult your physician.
It is recommended that you use Modius Spero for 30 minutes daily. As a safety feature, the device will automatically stop stimulation after 30 minutes of use.
The Modius Spero device has been designed to provide only one stimulation session per day. When a session is completed, the Modius Spero device cannot deliver another stimulation session until a period of at least 16 hours has passed.
Some users may have a response that may affect their ability to perform potentially hazardous tasks, such as operating a motor vehicle or heavy machinery for up to several hours after treatment. However, no significant lasting side effects have been reported.

Adverse Events

Clinical and research studies report the possibility of mild adverse effects including: skin irritation, discomfort from the stimulation, sensation of feeling off-balance, dizziness, nystagmus (eye movements), blurred or flashing vision, headache, nausea, and tinnitus.

The risk of these adverse effects occurring is usually mitigated by reducing or stopping the stimulation. If you do experience these adverse effects, stop stimulation by turning off or removing the device.

Manufacturer Information

Neurovalens
4th Floor, The Warehouse
7 James Street South
Belfast, United Kingdom
BT2 8DN

Medical Device Regulatory Approval via De Novo request

Neurovalens received FDA Regulatory approval for Modius Spero through De Novo Request, intended to treat symptoms associated with PTSD in May 2026.

More information

Disclaimer

This is s promotional webpage. The contents are not intended to be medical advice and should not be considered medical advice. You should consult healthcare professionals for medical guidance.