Introducing WAVETM
Introducing WAVETM
A next-generation medical device
for Pelvic Pain and Dysmenorrhea *
Current Indication of Use:
WAVE is a medical device for the treatment of sexual dysfunction which includes relief of pelvic pain. See: IFU VIDEOS
Off-Label Use (not FDA cleared):
WAVE is a medical device for the treatment of dysmenorrhea. It reduces menstrual pain symptoms, including cramps, abdominal pain and backache.
See: FLYER
WAVE is an FDA regulated, OTC, Class 2 medical device intended for home use. It is currently listed with the FDA under Product Code: KXQ (genital vibrator for therapeutic use). A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel’s exercise. Due to its low risk profile, WAVE is exempt from the FDA 510(k) pre-marketing clearance process.
As dysmenorrhea / menstrual pain is not considered a sexual dysfunction, Hush Tech is preparing a FDA 510(k) submission which will include clinical data that we believe supports an additional indication for the relief of dysmenorrhea. This use has not been approved by FDA because they have yet to evaluate our safety and efficacy data.
Click here for our current FDA regulatory status Click here for our NIH / FDA GUDID listing
This information will help HCP’s prescribe WAVE for the unapproved use of Relief from Dysmenorrhea/Menstrual Pain when they judge that the unapproved use is medically appropriate for their particular patient— whose characteristics and needs differ from the characteristics of the population(s) reflected in the approved use. The information presented here is compliant with current FDA Guidance.
WAVE is an OTC, reusable medical device for home use. The device generates vibratory stimulus at a nominal frequency of 142 hz, which is in the same frequency range as TENS devices, but employs a different mechanism of action. The vibration unit is attached via a thin flexible shaft that allows it to be comfortably inserted in the patient’s vagina for the recommended one (1) hour treatment period, after which the device is removed & cleaned. Clinical studies on WAVE’s predecessor devices have shown that a single one (1) hour treatment is normally sufficient to relieve or significantly reduce menstrual cramps for the duration of the patient’s cycle. Normally, no supplemenatary pain medication is required. See IFU
WAVE’s mechanism of action was postulated by Dr. Kermit T. Krantz to be:
“…… the pain was relieved through the mechanism of disturbing or stimulating (to the point of anesthetizing) the conductivity of the afferent pain fibers primarily in the utero-sacral ligaments and the Frankenhaüser plexus. The effect of the VIPON unit is similar to that of TENS units, uterosacral blocks which use lidocaine and other local anesthetics that have been employed to control labor pain and menstrual cramping.”
The vibratory stimulus (142 hz) is delivered through through a medical grade Stainless-Steel capsule with a rounded tip. This capsule is connected to a soft biocompatible jacket which extends continuously down the length of the shaft, forming a closed system covering all features with smooth and sealed transitions, and ending at the battery/power switch module. The shaft portion of the device is 100 mm in length and 4 mm in diameter. The shaft design (patent pending) is rigid enough to aid with the insertion of the vibrator, yet flexible enough to conform to different vaginal anatomies. The vibratory stimulus can be turned on and off at the battery/power switch module through a button on the side. The device is powered by a conventional single-use, Alkaline, watch battery. On the opposite side of the module there is a removable battery cover.
QUICK START GUIDE
Prepare WAVE for use:
1998
1999
2000
2002 to 2005
Our previous devices, VIPON and TAMIA, have been clinically proven to safely and effectively alleviate menstrual pain, without the need for OTC medication. WAVE, our latest innovation, builds upon the strengths of VIPON while addressing its limitations. Unlike its predecessors, WAVE is tampon-free, thereby making it possible to clean and reuse. Although clinical data for WAVE is still pending, non-clinical bench performance testing demonstrates that the vibratory stimulus it generates is comparable to VIPON, indicating its potential for similar effectiveness.
Clinical Practice Report:
Clinical Study Report:
Studies published in medical journals have shown that our prior devices, VIPON and TAMIA, are safe and effective in relieving menstrual pain. TAMIA was the mass produced version of the original VIPON investigational device. Unfortunately test marketing of Tamia showed that the retail price was too high for a single use, tampon based device. As a result, production of Tamia was discontinued.
WAVE is our latest third-generation device that which was developed to address the shortcomings of the TAMIA device. Unlike the VIPON / TAMIA devices, WAVE does not incorporate a tampon, allowing it to be easily cleaned and reused. The VIPON’s therapeutic effect is directly correlated with the amplitude and frequency of the vibratory stimulus it generates. While clinical data is not yet available for WAVE, non-clinical bench tests comparing it to VIPON has shown that WAVE generates a vibratory amplitude and frequency that is substantially equivalent to VIPON. It is therefore reasonable to conclude that the therapeutic effect of WAVE is substantially equivalent to VIPON, which has already undergone successful clinical trials.
WAVE is classified under FDA product code KXQ: genital vibrator for therapeutic use. This product code is exempt from FDA 510(k) clearance requirements because the FDA has limited safety concerns about this class of devices.
WAVE is made from passivated 304L medical grade stainless steel and certified biocompatible plastics. Wave has also passed biocompatibity testing (Cytotoxicity, Sensitizatiion and Vaginal irritation) conducted by NAMSA, an indepedent testing lab.
The device is powered by a conventional and disposable, 1.5 Volt LR44 alkaline watch battery and presents no electrical shock hazard to the user.
David Conroy is a product designer and engineer with 35 years of experience in development primarily in the Medical and Scientific sectors. Having worked on the forerunner of Wave for 20 years, David undertook a major redesign in 2021 to bring about WAVE. David is an advocate for Women’s health.
Charles Tepper, is an electrical engineer with a history of entrepreneurial success and angel investing. A chance meeting with the inventor of the VIPON, Steven Kilgore, in 2000 sparked his interest, leading to his financial backing for the crucial VIPON Clinical Trials in 2002. Currently, he is dedicated to FDA submissions / compliance and marketing efforts.
Dr. Laura N. Homewood, MD, is a gynecologic surgeon with a lifelong passion for advancing women’s health outcomes. As Hush Tech’s Medical Advisor, she plays a key role in monitoring user experience, evaluating clinical data for potential new indications and supporting FDA submissions.
Robin Roschke is an experienced Chief of Staff and strategic advisor known for mobilizing complex projects and driving actionable roadmaps for high-growth organizations. As Special Advisor to the Managing Partner, she plays a critical role in positioning Hush Tech for sustainable growth.
Dennis Crane is a regulatory, clinical & quality expert with over 40 years of medical device industry experience, primarily in the USA. Dennis provides support for our FDA submissions as well as regulatory guidance.
Carol McCrae is a New York State Certified Public Accountant with 7 years experience as a CPA at a Big Four accounting firm and 17 years in her own firm. As the accountant at Hush Tech, she is responsible for all of the financial reporting and tax matters for the company.
Alice Curiel is a digital marketing & graphic design professional with over a decade of experience. As Hush Tech’s Creative Director, she is responsible for conceptual development and management of Hush Tech’s branding and social media campaigns.
We know you want what’s best for the women you treat, whether they have dysmenorrhea or another pelvic pain condition. To help you evaluate if WAVE is right your patients, contact us today to get more information or write us at: [email protected]
WAVE™ by Hush Tech
240 West 75th Street
New York, NY 10023
WAVE™ by Hush Tech
240 West 75th Street
New York, NY 10023
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