The personal data that Wave Neuroscience collects, uses, stores, and discloses includes the following: personal identifiers; customer records; commercial information; protected classification characteristics; wellness data (such as electrical activity of the brain and/or heart and data related to the use of Wave products); inferences drawn from other personal information; age or date of birth; personal data about children under the age of 16.
Wave Neuroscience may use your personal data for the following purposes: to operate and provide features of its products and services; to understand, improve, and personalize its products and services; to provide customer support; to protect against fraud or security threats; to process payments; to communicate with you for business, marketing, or fundraising purposes; as part of law enforcement, judicial, and administrative proceedings as required by law; in the event of an acquisition or other change of control; or as part of a research initiative internal to Wave Neuroscience or in collaboration with third parties.
Wave Neuroscience’s services and data are hosted and operated in the United States (U.S.) by Wave Neuroscience itself and by its service providers. If you do not reside in the U.S., laws in the U.S. may differ from the laws where you are located. By using Wave Neuroscience products and services, you acknowledge that personal data about you is being provided to Wave Neuroscience in the U.S. and will be hosted on U.S. servers, and you authorize Wave Neuroscience to transfer, store and process your information to and in the U.S., and possibly other countries. You hereby consent to the transfer of your data to the U.S. as set forth herein. Wave Neuroscience will not disclose or sell your personal data to any third party for purposes not described above without first obtaining your written authorization.
EEG/ECG General Information
An electroencephalogram (EEG) is a noninvasive test that measures and records electrical activity of the brain. Similarly, an electrocardiogram (ECG or EKG) is a noninvasive test that measures and records electrical activity of the heart. Wave Neuroscience uses an EEG and ECG in combination, which the user can obtain from a Wave Neuroscience representative and/or facility, or from an independent facility, solely for general and informational purposes, as well as for programing the NEST user’s personal passport module, and NOT for screening for or diagnosing any neurological or cardiac disorder or medical condition.
NEST General Information
The NEST includes a headset, base station, power cord, and personal passport module (PPM) programmed in accordance with the user’s EEG data. The NEST is a general wellness product, pursuant to U.S. Food and Drug Administration (FDA) guidance. A general wellness product has (1) an intended use that relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use that relates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.
NEST Headset General Information
The NEST headset is a non-invasive, non-painful, non-electrical stimulation, non-laser, not-radiation exposure, head-mounted device that utilizes magnets set to rotate at a personalized frequency based on the user’s EEG and ECG.
POSSIBLE SIDE EFFECTS
EEG/ECG: The user may experience slight redness or abrasion in the area where the electrodes are placed, as well as allergic reaction to the electrode-tip material.
NEST headset: Users may experience head, neck, or back pain from prolonged wearing of the NEST headset. The user should immediately cease use of the headset if s/he experiences any neck/back pain, headache, or skin irritation that cannot be tolerated or interferes with use of the headset.
As a head-mounted device, the headset’s inner surface may not match every head shape. The user should adjust the headset and use the magnet adjustment knobs to obtain the best possible fit.
The headset will generate noise up to 75 dBA, which is less than normal roadside noise. However, the user should immediately cease use of the headset if s/he experiences discomfort or ringing in the ears, or any hearing loss.
After performing the EEG/ECG, Wave Neuroscience records and analyzes the resulting data for general and informational purposes, as well as to program the user’s personal passport module. The EEG/ECG report does not constitute and is not a substitute for a medical diagnosis or medical advice and is not used to treat any medical condition. The user should not construe, rely upon, or interpret the EEG/ECG report as providing a diagnosis, treatment, or medical advice. To obtain a diagnosis or treatment plan for a medical condition, or general medical advice, the user should consult a qualified medical professional.
Wave Neuroscience uses the EEG/ECG report to enable daily, personalized, 30-minute sessions that can support improved focus, stress management, mood, and sleep quality, among other salutary effects. NEST users commonly report a combination of benefits, including:
- Improved quality of sleep
- Improved ability to manage stress
- Improved concentration and focus
- Improved mood
- Increased motivation
- Improved mental acuity
- Improved ability to follow instructions
- Improved ability to quickly alternate between tasks
- The NEST is not a medical device and is not regulated by the FDA as a medical device. Since it is not an approved medical device, it cannot be billed through insurance.
- The NEST is not intended to diagnose, treat, cure, or prevent any medical condition. The NEST is a wellness device intended to encourage and inform healthy lifestyle choices.
- This product is not a substitute for medical advice and care. If users have any questions or concerns about a medical condition, they should consult a qualified healthcare professional.
- The NEST does not perform brain training or train users’ brains. Brain training is a medical term regulated by the FDA.
USE CRITERIA – PLEASE READ CAREFULLY
ALMOST ANYONE CAN USE THE NEST, WHETHER YOU ARE AN ELITE ATHLETE, EXECUTIVE, OR ANYONE LOOKING TO IMPROVE YOUR WELL-BEING. HOWEVER, YOU SHOULD NOT USE THE NEST IF YOU:
- ARE UNDER THE AGE OF 16.
- ARE OR COULD BE PREGNANT.
- HAVE A HISTORY OF SEIZURES.
- HAVE IMPLANTS CONTROLLED BY PHYSIOLOGIC SIGNALS – CARDIAC PACEMAKER, IMPLANTED MEDICATION PUMP, OR INTRA-CARDIAC LINES.
- The NEST should not be used by those who have an implanted device that is activated or controlled in any way by physiologic signals, even if the device is located beyond 20 cm distance from the magnetic treatment surface. This includes cardiac pacemakers, implanted medication pumps, and intra cardiac lines. Failure to follow this restriction could result in serious injury or death.
- HAVE AN INTRACRANIAL IMPLANT – INTRACRANIAL IMPLANTED DEVICES OR METALLIC OBJECTS WITHIN THE HEAD
- The NEST should not be used by those who have intracranial implanted devices (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or metallic objects within or near the head. Likewise, the NEST should not be used on patients with bullets, or bullet fragments, facial tattoos with metallic ink, or magnetically activated dental implants. The magnetic field created by the NEST during use could affect these implants or objects resulting in movement, heating, or other unforeseen issues. Otherwise, serious injury could result.
CONSENT, RELEASE AND WAIVER OF LIABILITY
Please read this consent, release, and waiver of liability statement carefully so you understand it before signing.
Wave Neuroscience makes no representations or guarantees that the NEST will provide therapeutic benefits to its users.
Limitation of Liability
Wave Neuroscience does not assume any liability and will not be liable for damages of any kind, whether direct, indirect, incidental, special, exemplary, or consequential damages, arising out of the use of or inability to use the NEST, regardless of whether Wave Neuroscience has advised me of the possibility of any such liability.
I have read and understand the disclosures above and hereby consent to receive an EEG and ECG (if using a Wave Neuroscience-affiliated facility and/or device) and an EEG/ECG report, and I authorize Wave Neuroscience to perform these assessments and subsequent analysis. I understand the above ‘Important Notes’ and ‘Contraindications’ statements, and I do not have any of the conditions described therein. If I elect to use a NEST, I hereby consent to use the NEST for non-medical purposes and only after consuming and understanding the NEST user manual and training materials.
I understand that I am the only person authorized to use this device. I will return it in full working order by the expected return date unless an authorized Wave Neuroscience employee approves or coordinates a change. I am responsible for damages if any part or component of the NEST is damaged, lost, or stolen.
I will not use the NEST until I have fully read and understand the NEST user manual and training material and have watched the video provided to me with the NEST. If I have any questions about use of the NEST, I understand I can reach a Wave Neuroscience representative at +1.858.358.5109 on weekdays from 9 AM to 5 PM Pacific Time, or via email at firstname.lastname@example.org.
Release and Waiver of Liability
I have read and understand the potential risks involved in receiving an EEG/ECG and in my use of the NEST, and I expressly assume such risk and all related liability and expense resulting therefrom. I have been provided the telephone number and email address for a Wave Neuroscience representative that I can contact with any questions about the EEG/ECG or the NEST and its use. I understand that it is my obligation to use the NEST in accordance with the safety requirements and instructions provided in the user manual.
Release: I agree to release, indemnify and hold harmless Wave Neuroscience and its respective affiliates, officers, agents, employees, subcontractors, insureds, and permitted successors and assigns against any and all claims, losses, damages, liabilities, penalties, punitive damages, expenses, reasonable legal fees and costs of any kind or amount whatsoever, which result from the performance and use of the EEG, and use or inability to use, and performance of, the NEST.
Indemnification: To the fullest extent permitted by law, I agree to defend, indemnify and hold harmless Wave Neuroscience and its affiliates, officers, directors, members, representatives, agents, employees, contractors, attorneys, successors, and assigns harmless from and against any and all claims, demands, actions, right of action (at law or in equity) because of any injury (including death) or damage to person or property arising from the performance of the EEG/ECG and/or from my use of the NEST, including, but not limited to, any negligent act or omission of Wave Neuroscience.