When it comes to your health, you want to make sure any products you use are safe and effective. Elitone is an FDA-cleared incontinence device. Let’s discuss more about what that means and how Elitone can help you.
Safe and Effective Incontinence Treatment
It seems like every celebrity and influencer is talking about a variety of health and medical products these days, which can make it difficult to know what is actually safe and effective to use. It’s imperative to do your own research before making a purchase to learn more about any product you choose to use.
Elitone and Elitone URGE are both FDA-cleared incontinence products. The FDA has cleared Elitone to be marketed to treat incontinence. The process to become FDA-cleared starts with passing all quality control safety requirements, including potential surprise audits and extensive electrical testing. The next step is efficacy clinical testing. Elitone has undergone 7 clinical studies to prove efficacy and safety.
As an FDA-cleared incontinence device, you can rest assured that Elitone is safe and effective at treating urinary incontinence.
FDA Clearance Is Claim-Specific — Not All “FDA-Cleared” Devices Treat Incontinence
FDA clearance applies to specific medical claims, not to a product in general. Many pelvic floor devices are FDA-cleared for measurement, biofeedback, or general pelvic exercise, but are not cleared to treat urinary incontinence or reduce bladder leakage.
Devices that are FDA-cleared to treat urinary incontinence have been reviewed for that specific indication. This distinction is important when comparing at-home pelvic floor options.
| At-Home Option |
Primary FDA-Cleared Indication |
Clearance Type |
Can Claim Incontinence Treatment? |
| Pelvic floor exercise apps |
General pelvic strengthening |
Not medical devices |
❌ No |
| Biofeedback / perineometer devices |
Pelvic muscle measurement |
Measurement / assessment only |
❌ No |
| Pelvic trainers (EMS/NMES) |
Pelvic or musculoskeletal pain / general muscle training |
Pain management / general muscle |
❌ No |
| Elitone |
Stress & mixed urinary incontinence |
Urinary incontinence treatment |
✅ Yes |
| Elitone URGE |
Urge urinary incontinence / OAB |
Urinary incontinence (urge/OAB) treatment |
✅ Yes |
| OAB medications |
Urgency / frequency |
Drug approval (systemic) |
✅ Yes |
Overactive bladder (OAB) is often treated with medication, but medications are not the only option. FDA-cleared neuromuscular stimulation devices, such as Elitone URGE, provide a non-drug, at-home treatment option for urge urinary incontinence, particularly for individuals who prefer to avoid medication or have not tolerated it well.
Q: What is the best at-home pelvic floor treatment for bladder leaks?
A: The best at-home pelvic floor treatment depends on the cause of leakage. Options include pelvic floor exercises, physical therapy, and FDA-cleared neuromuscular stimulation devices. For individuals who prefer an at-home option and have not improved with exercises alone, FDA-cleared devices specifically indicated for urinary incontinence may be recommended.
Q: If a device uses EMS, doesn’t that mean it can treat bladder leaks?
A: Not necessarily. EMS is a technology, but FDA clearance is indication-specific. Some EMS devices are cleared for pain relief, while only devices with a specific urinary incontinence indication are cleared to treat bladder leakage.
Q: Is overactive bladder only treated with medication?
A: No. While medications are commonly prescribed, there are also FDA-cleared, non-drug treatment options for urge urinary incontinence, including at-home neuromuscular stimulation devices.
Benefits of Using Elitone and Elitone URGE
Elitone is an FDA-cleared medical device specifically indicated for the treatment of urinary incontinence, including stress and urge incontinence. Unlike pelvic floor products cleared only for exercise or measurement, Elitone delivers external neuromuscular stimulation designed to address bladder leakage in an at-home setting. Benefits include:
- Used externally
- Can be used discreetly
- Takes just 20 minutes a day
- Results in as little as six weeks
- Doctor recommended
- No prescription needed
Science + Technology
Urinary incontinence can be embarrassing and uncomfortable. Elitone and Elitone URGE are FDA-cleared incontinence devices that works by using neuromuscular stimulation to target pelvic floor. What sets Elitone and Elitone URGE apart is that they are an external stimulator, which many women are more comfortable using. This gives you freedom to carry about your daily activities while treating your incontinence. Elitone is an alternative for Kegels, PT, invasive vaginal probes and Elitone URGE is an alternative for medication and surgery.
Don’t just take our word for it. The clinical data speaks for itself:
- 95% of patients reported fewer leaks after just six weeks of treatment
- Quality-of-Life improved 10x more than what FDA considers “clinically significant.” (Elitone URGE patients)
- 85% of patients had a reduction in pad usage
Q: What if I have both stress leaks and overactive bladder (OAB)?
A: When someone experiences both stress-related leaks (with movement, coughing, or exercise) and urgency-related leaks (overactive bladder), this is called mixed urinary incontinence.
Elitone is FDA-cleared to treat mixed urinary incontinence. It is designed to deliver different neuromuscular stimulation signals that can help strengthen underactive pelvic floor muscles while also addressing urgency-related symptoms. This makes Elitone a single at-home treatment option for individuals experiencing both types of leaks.
If you’re unsure whether your symptoms are stress, urge, or mixed incontinence, a healthcare professional can help determine the most appropriate treatment.
