Please read carefully and completely before signing. Ask your provider any questions you may have.
Important — Please Read Before Signing
The bioSense™ is a wellness monitoring device — not a medical device. It is designed to monitor general wellness indicators and provide biometric health data. It is not intended to diagnose, treat, cure, or prevent any disease or medical condition. It is not a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional for any medical concerns.
Section 1
Description of the bioSense™ Wellness Device
The bioSense™ (the "Device") is a custom-fabricated intraoral wellness appliance manufactured from biocompatible dental materials. The Device is designed to be worn during sleep and contains embedded sensor technology that passively monitors the following wellness metrics:
Heart rate and heart rate variability (HRV)
Blood oxygen saturation (SpO₂) — for wellness monitoring purposes only
Respiratory rate patterns during sleep
Body temperature fluctuation
Jaw muscle activity and movement (bruxism/clenching activity monitoring)
Physical movement and sleep position
This biometric data is transmitted to the byteSense mobile application ("the App") and presented as a daily wellness score and detailed health metrics. The Device also provides occlusal protection consistent with a custom-fit dental splint.
Section 2
Regulatory Classification & Intended Use
I understand and acknowledge each of the following:
The bioSense™ is a consumer wellness device, similar in regulatory classification to consumer fitness trackers, smartwatches, and other wellness wearables (e.g., Apple Watch, Oura Ring, WHOOP). It is not classified as a medical device by the FDA for diagnostic or therapeutic purposes.
The bioSense™ is not intended to diagnose, treat, cure, or prevent any disease or medical condition, including but not limited to sleep apnea, cardiovascular disease, bruxism-related pathology, or any other medical condition.
The wellness data provided by the Device is for personal health awareness purposes only and should not be used as the basis for any medical decision without consulting a qualified healthcare provider.
If the Device data reveals patterns that concern me — including but not limited to low blood oxygen readings, irregular heart rate patterns, or significant grinding activity — I understand it is my responsibility to consult a qualified physician or specialist for appropriate evaluation and care.
The Device is not a substitute for any prescribed medical therapy, sleep study, or physician-directed treatment. Use of this Device does not replace, alter, or supersede any existing or recommended medical care.
Section 3
Custom Fabrication & Financial Acknowledgment
I understand the bioSense™ is custom-fabricated from my specific dental scan and cannot be returned, resold, or used by another person. By authorizing fabrication, I understand that the Device is non-refundable once laboratory fabrication has commenced.
I understand that the bioSense™ is a patient-pay wellness investment and is not covered by dental or medical insurance at this time. I accept financial responsibility for the agreed investment amount of: $___________
I understand that HSA (Health Savings Account) and FSA (Flexible Spending Account) funds may be applicable and that I am responsible for confirming eligibility with my plan administrator.
Section 4
Data Collection & Privacy Authorization
I authorize byteSense Inc. to collect, store, and process my biometric wellness data as described in the byteSense Privacy Policy available at bytesense.ai. I understand that my data is used to generate my wellness reports and may be used in de-identified, aggregated form to improve the byteSense platform and contribute to health research.
I understand that my dental practice may have access to my byteSense data for the purpose of supporting my wellness experience. I consent to this data sharing between byteSense and my dental provider.
I understand that my personal identifiable information will not be sold to third parties. For complete privacy information, including data retention and deletion rights, I may review the byteSense Privacy Policy at bytesense.ai or contact support@bytesense.ai.
Section 5
Risks, Limitations & Patient Responsibilities
I have been informed of and acknowledge the following:
As with any intraoral appliance, a brief adjustment period of approximately 1–2 weeks is expected. Some patients experience increased salivation, minor speech changes, or temporary discomfort during adjustment.
The Device must be cleaned daily as instructed by my dental provider. Failure to maintain the Device may affect comfort, longevity, and sensor performance.
The Device should be stored in its provided case when not in use and should not be subjected to high heat, which may cause distortion of the dental material.
Biometric sensor readings are wellness indicators — not clinical measurements. Accuracy may vary based on individual anatomy, Device fit, and usage conditions.
I agree to attend all scheduled delivery and follow-up appointments as recommended by my provider.
For technical issues with the Device or App, I may contact byteSense support at support@bytesense.ai.
Section 6
Warranty Acknowledgment
I understand the bioSense™ Device carries a 12-month warranty from date of delivery covering manufacturing defects. The warranty does not cover loss, damage due to improper care or use, accidental breakage, or normal wear over extended use.
Final Acknowledgment
Patient Certification
I certify that I have read and fully understand this Consent Form. I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction. I voluntarily consent to receive the bioSense™ Wellness Device and authorize my dental provider to proceed with intraoral scanning for device fabrication. I understand that this device is a wellness monitoring product and is not a medical device.
Patient Signature & Authorization
GUARDIAN / AUTHORIZED REPRESENTATIVE (if patient is a minor or unable to sign)
Practice Use Only — To Be Completed at Case Submission
