This document guides the types of affiliate promotional activity that are acceptable and unacceptable.  This guidance augments the Affiliate Terms and Conditions agreement that must be signed and complied with for ongoing participation in the Elitone Affiliate Program. When referring to “Elitone’s” that includes both Elitone and Elitone URGE devices and assets.

As specified in the Affiliate Terms and Conditions document, affiliates are:

• Not authorized to represent or act on behalf of Elidah.
• Not authorized to respond to product complaints. If you become aware of a product complaint the information should be immediately forwarded to customercare@elitone.com or 978-435-4324.
• Not authorized to provide medical advice on behalf of Elidah
• Not authorized to distribute product information or respond to customer inquiries beyond the scope of information that is publicly available on the elitone.com website.

This guidance document will be updated as needed.  It is the responsibility of the affiliate to utilize the most current document revision available from elitone.com

WHEN IN DOUBT…. ASK

Promotional Assets

Elidah can provide promotional assets (i.e. “Licensed Materials”) for use by affiliates, including:

• Elitones’ logos
• Product photos and renderings
• Advertising copy
• Elitones’ user manual

These assets will be updated as needed.  It is the responsibility of the affiliate to identify and utilize the most current assets in their promotional activities.   If you have a promotional idea that would require the use of new/different Elitones assets please contact customercare@elitone.com.

Types of Promotional Activity

This program is intended to provide a means for affiliates to be compensated for expanding the marketing reach of elitone.com.  Affiliates may use one or more of the following types of promotional activity to reach new prospective Elitone customers.

• Social Media Posts (e.g. Facebook, Instagram, Twitter)
• Email Distribution
• Face-to-face meetings
• Online Stores

Some forms of promotional activity are not permitted.   See the Affiliate Terms and Conditions agreement for comprehensive requirements.  Per the terms of the agreement, Elidah reserves the right to prohibit any promotional activity by an affiliate. Examples of prohibited promotional activities include:

• Spamming
• Promotion to populations that are not candidates for the Elitones
• Promotion to populations outside of the US

If you are considering whether a promotional activity is permissible contact affiliate@elitone.com.

Acceptable Language

Certain promotional activities will utilize written content.  Because the Elitones are medical devices, the language used in these promotional activities must be compliant with applicable regulations.  The following list identifies generally acceptable language for use in Elitone promotional activity. Per the terms of the agreement, Elidah will regularly review promotional materials generated by its affiliates and reserves the right to prohibit their ongoing use.  If you are considering whether certain promotional language is permissible contact customercare@elitone.com.

GENERAL

• Language should be consistent with the product labeling. See the current ELITONE Indications for Use.
• Elitone should have first letter capitalized, unless where it references web or email addresses. ‘URGE’ within Elitone URGE should be in all capitalization
• GelPad should be written as one word and the “P” should be capitalized.
• If the order of the words changes within a phrase that is deemed the same intent then the same rules apply.
• Elitone and Elitone URGE may be referred to as Elitone/Elitone URGE (when appropriate), preferred: product, therapy, treatment, solution, muscular stimulation, neuromuscular stimulation, stimulation
• acceptable: stimulator, electrical stimulation, device, machine,, wearable, invention, aid, remedy, tool, surgery alternative.
• Users may be referred to as women, ladies, females, users, customers, sufferers, moms, mothers, gals, Senorita.

CONDITION/ ISSUE

• When referring to the broad condition, without reference to the product/therapy it may be referred to as incontinence, urinary incontinence, bladder leakage, or bladder incontinence.
• Elitone: treats stress incontinence, or stress urinary incontinence (or SUI), as well as mixed incontinence, or mixed urinary incontinence (or MUI).
  • Anatomy: pelvic floor, pelvic floor muscles, pelvic muscles, Kegel exercise muscles
• Elitone URGE: treats (preferred) overactive bladder (or OAB), (secondary) urge urinary incontinence (or UUI) (although it is often easier to say stress and urge incontinence if speaking about both)
  • Anatomy: bladder nerves and muscles
• Anatomy for both: pelvic floor, pelvic floor muscles, perineal muscles, perineal tissues

USE AND RESULTS

• The following activities/situations may be referred to as causes of leaks: coughing, sneezing, dancing, laughing, jumping, running, walking, hiking, or other physical activity. (less clear on cause of OAB)
• Verbs that may be used to describe the result of product use include: treat, cure, help, improve, heal, recover, remedy, rejuvenate, restore, revive, fix, alleviate, mend, make healthy, make well, make sound, make whole, vitalize, activate, tone, exercise, stimulate.
• References may be made to Kegel exercises including phrases like: does Kegels for you, like Kegels, exercises for you. (Elitone only)
• Results from multiple clinical studies may be referenced (at least 5 clinical studies):

The results from stress and urge studies are so similar you can generally say regarding both:

• 95% of subjects improved, and an average of > 70% leak reduction in a short 6 weeks (whereas they were incontinence for 10 years before the study)
• 75% of subjects achieved a clinically significant reduction in leaks per day (aka they were “responders” = greater than 50% improvement.)
• All 22 questions in Quality of Life questionnaire improved
• >90% improved their Quality of Life
• Pad usage dropped by 60% or more.
• 89% of subjects would replace what they were previously doing with Elitone
• 100% of subjects reported that the comfort of the electrode and stimulation were suitable
• There were no adverse events that resulted in an injury or health risk.

• More specifically on Urge study
  • Quality of Life improved 10x more than what the FDA considers significant!
  • 97% of women improved, 85% of women considered were responders
• When referring to the number of women impacted by SUI: millions of women, up to 35% of women, 1 in 3 women.

Unacceptable Language

Elitone is a medical device that is cleared for sale under specific regulatory requirements.  These include requirements about product marketing, and more specifically, what can and can’t be legally said about the product.   The following are examples of promotional language that is not permissible about Elitone.  If you are questioning the suitability of the language included in your Elitone promotion contact customercare@elitone.com for guidance.

Unacceptable Verbiage for Elitone

• Stating or inferring that the device treats primarily “urge incontinence” or its symptoms (e.g. sudden urge to urinate).
• Stating or implying that the device strengthens the pelvic floor muscles
• Stating or implying that the device treats medical conditions other than SUI or MUI.
• Stating or implying that the device can/should be used by someone with any of the contraindications identified in the product labeling (for example, by someone pregnant).
• Any language that is inconsistent with the product labeling.
• Should not imply use for “severe” sufferers
• FDA approval of Elitone or any other language that implies that the FDA supports or advocates the device. Can say FDA cleared.
• Using a testimonial to circumvent any of the above unacceptable uses.

Unacceptable Verbiage for Elitone URGE

• Stating or inferring that the device treats “stress incontinence” or its symptoms (e.g. urinate when coughing, laughing, jumping). This includes the use of “incontinence” without the descriptor “urge” when discussing the product/therapy.
• Stating or implying that the device treats medical conditions other than UUI or OAB
• Stating or implying that the device can/should be used by someone with any of the contraindications identified in the product labeling (for example, by someone pregnant).
• Any language that is inconsistent with the product labeling.
• Should not imply use for “severe” sufferers
• FDA approval of Elitone URGE or any other language that implies that the FDA supports or advocates the device. Can say FDA cleared.
• Using a testimonial to circumvent any of the above unacceptable uses.

Unacceptable Imagery

• Should not imply use cases that are inconsistent with the product labeling
• Should not imply use by men
• Should not imply use while pregnant
• Should not show photographs revealing private parts of the pubic or perineal area of a woman