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FDA ClearedIBS Abdominal Pain

Safe & Simple Relief for IBS abdominal pain

GiCalm is an FDA-cleared, wearable prescription medical device indicated as an aid in the reduction of functional abdominal pain associated with Irritable Bowel Syndrome (IBS) in patients ages 11-18. It is designed to be comfortably worn on one ear for approximately five days (120 hours) each week, for up to three consecutive weeks. GiCalm is prescribed and applied by a qualified healthcare professional. It does not cure IBS.

Medication-free · Non-surgical · Clinician-applied

Medication-freeNon-surgicalClinician-appliedNo anesthesiaAges 11-18No implants
A man's transformation from opioid withdrawal discomfort to a calm state of recovery at sunset
5
day wear period per week
3
consecutive weeks of treatment
11-18
patient age range
2-3
months follow-up relief observed

When IBS begins to change your child's life

Common experiences described by patients. GiCalm may offer an alternative worth discussing with your provider.

My child never knows when the pain is going to start.

They used to love school, but now they're afraid to go.

We've missed birthday parties, sports practices, even vacations because of stomach pain.

We've tried diets, medications, probiotics... and the pain still comes back.

It just hurts all the time.

I don't want to be the kid who always cancels.

Why standard treatments can fall short

The gaps patients and providers describe most often — friction points that delay or derail the start of treatment.

01

Dietary modifications may not fully address functional abdominal pain

02

Medications may have limited effectiveness

03

Lifestyle adjustments alone may not provide adequate relief

04

Behavioral therapy may not resolve symptoms for all patients

A different approach

GiCalm device
Principle
01

Delivers gentle electrical signals through specific nerve branches in the outer ear, including the vagus nerve, that are connected to pathways involved in pain perception and sensory processing

Principle
02

Helps regulate how the nervous system interprets abdominal pain signals

Principle
03

Medication-free — does not change digestion or bowel function

Principle
04

Non-surgical and minimally invasive — four tiny microneedles placed on the outer ear

Principle
05

Simple, brief in-office application without anesthesia

What patients commonly report

01

Reduced severity of abdominal pain episodes

02

Reduced duration of abdominal pain episodes

03

Reduced frequency of abdominal pain

04

Overall reduction in abdominal pain burden

05

Pain relief that continued after the treatment period ended

Individual results may vary

What to expect

01
Stage 01 of 04

Initial consultation

A licensed healthcare provider evaluates your child and determines if GiCalm is appropriate.

02
Stage 02 of 04

Brief in-office placement

No anesthesia or sedation required. The device is placed on the outer ear.

03
Stage 03 of 04

Continuous wear (~5 days)

Worn for approximately 120 hours. Most normal daily activities can continue.

04
Stage 04 of 04

Removal and reassessment

Device is removed in-office. Repeated weekly for up to 3 weeks as directed.

  • 01Class II FDA-cleared medical device
  • 02No serious adverse events or complications reported in clinical studies
  • 03Reported side effects were rare, generally mild and temporary
  • 04GiCalm is not MRI-compatible and is not recommended during pregnancy or in patients with certain implanted electrical devices unless cleared by a specialist
  • 05Appropriateness for treatment is determined by a licensed healthcare provider

Questions about GiCalm

GiCalm is a prescription medical device. This webpage is for informational purposes only and does not provide medical advice. Patients should consult a licensed healthcare provider to determine whether GiCalm is appropriate for them. Distributed by MAI Medical USA Inc.

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