This document provides guidance regarding the types of Affiliate promotional activity that are acceptable and unacceptable. This guidance augments the Affiliate Terms and Conditions Agreement that must be followed for ongoing participation in the ELITONE Affiliate Program.
As specified in the Affiliate Terms and Conditions Agreement, 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 email@example.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.
WHEN IN DOUBT…. ASK
Elidah provides promotional assets (i.e. “Creative” materials) for use by Affiliates, including:
- ELITONE logos
- Product photos and renderings
- Advertising copy
- ELITONE 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 use of new/different assets please contact firstname.lastname@example.org.
Types of Promotional Activity
This program provides a means for Affiliates to be compensated for expanding the marketing reach of ELITONE. Affiliates may use one or more of the following types of promotional activity to reach new prospective customers.
- Social Media Posts (e.g. Facebook, Instagram, Twitter)
- Email Distribution
- Face-to-face meetings
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:
- Promotion to populations that are not candidates for ELITONE
- Promotion to populations outside of the US
If you are considering whether a promotional activity is permissible contact email@example.com.
Certain promotional activities will utilize written content. Because ELITONE is a medical device, it is imperative that the language uses in these promotional activities is compliant with applicable regulation. 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 there ongoing use. If you are considering whether certain promotional language is permissible contact firstname.lastname@example.org.
- Language should be consistent with the product labeling. See the current ELITONE Indications for Use.
- ELITONE should be in all caps, except for use in web addresses or email addresses.
- GelPad should be written as one word and the “P” should be capitalized.
- The product/therapy may referred to as: ELITONE, device, product, therapy, treatment, stimulation, stimulator, GelPads, electrical stimulation (also estim or e-stim), neuromuscular stimulation, equipment, appliance, gadget, gear, wearable, invention, aid, remedy, machine, tool, surgery alternative.
- The relevant anatomy may be referred to as: pelvic floor, pelvic floor muscles, pelvic muscles, Kegel exercise muscles, perineal muscles, perineal tissues
- When referring to ELITONE product/therapy the condition should be referred to as: stress incontinence, stress urinary incontinence (or SUI).
- When referring to the broad condition, without reference to the product/therapy it may be referred to as: incontinence, urinary incontinence, bladder leakage, bladder incontinence.
- Users may be referred to as: women, ladies, females, users, customers, sufferers, moms, mothers, gals.
- The following activities/situations may be referred to as causes of leaks: cough, sneeze, dance, laugh, jump, run, walk, hike, or other physical activity.
- 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.
- Results from a published clinical study may be referenced including:
- Clinically proven
- Leak measures:
- 95% of subjects reduced their daily leaks within 6 weeks. This must be paired with a statement or footnote that average leaks per day was reduced by 71%.
- 75% of subjects achieved a clinically significant reduction in leaks per day
- Quality of Life measures:
- 90% of subjects have improved Quality of Life
- 85% of subjects achieved a clinically significant improvement in quality of life.
- 89% of subjects would replace what they were previously doing with Elitone
- 83% of subjects were satisfied with treatment
- Pad usage was reduced by 57%
- 67% of subjects achieved a clinically significant reduction in pad usage
- 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.
- When referring to the number of women impacted by SUI: millions of women, up to 35% of women, 1 in 3 women.
ELITONE is a medical device that is cleared for sale in accordance with specific regulatory requirements. These include requirements pertaining to 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 in reference to ELITONE. If you are questioning the suitability of language included in your ELITONE promotion contact email@example.com for guidance.
- Stating or implying that the device strengthens the pelvic floor muscles
- Stating or implying that the device treats urge incontinence or overactive bladder
- Stating or implying that the device treats any medical condition other than SUI.
- 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 who is pregnant).
- Use of any language inconsistent with the product labeling.
- Referring to the device as a TENS machine
- Stating or implying that the device is for women with “severe” symptoms
- Use of the term “FDA approved” or any other language that implies that the FDA supports or advocates the device. Note that use of the term “FDA cleared” is acceptable.
- Use of a testimonial to circumvent any of the above unacceptable uses.
Elidah provides imagery for your use in promoting ELITONE. These include logos, product photos and other imagery. They can be accessed on the Affiliate page.
Affiliates may create their own imagery for use in promoting ELITONE. Affiliate generated imagery may incorporate the imagery provided by Elitone.com or may be original imagery created by the affiliate. All imagery must comply with the Affiliate Terms and Conditions and additional requirements defined in this guidance document. Elitone.com reserves the right to use and share any Affiliate generated imagery that includes use of the ELITONE trademark or a photo or representation of the ELITONE product.
Elitone.com reserves the right to prohibit use of any Affiliate imagery related to ELITONE. If you are questioning the suitability of imagery that will accompany your promotion of ELITONE, firstname.lastname@example.org for guidance.
Specific imagery that is not considered appropriate includes those that show or imply:
- use that is inconsistent with the product labeling
- use by men
- use while pregnant
- private parts of the pubic or perineal area of a woman
Updated – 11/27/19