Age-Verification Human Factors Study
Validation of the IKE Bluetooth® Low Energy System for Age-Gating and Control of an ENDS Device: A Multi-Center Human Factors Study
A comprehensive human factors validation study was conducted to evaluate the effectiveness of the IKE Bluetooth® Low Energy System in age-gating and controlling an Electronic Nicotine Delivery System (ENDS) device.
This study assessed the IKE application user interface, mitigated potential use-related hazards through observational analysis of participants interacting with the IKE application and a test device, and evaluated participant feedback.
The IKE Bluetooth® Low Energy System, integrated on a System-on-Chip (SoC) with an interactive on-market user interface, was tested in simulated-use environments with representative user populations. Results indicate high efficacy in age verification, with 100% of participants successfully completing the process, though challenges in device deactivation post-idle time were identified. These findings are under review by the U.S. Food and Drug Administration (FDA) as part of a Pre-Market Tobacco Application (PMTA) for the IKE Bluetooth® Low Energy System on a Chip.
The study was designed to assess three things:
- Whether participants could successfully download and use the IKE application
- Whether the system prevented individuals under 21 from activating a device
- Whether the system allowed individuals 21 and older to activate a device
In controlled testing with 102 participants:
- The system prevented underage device activation in every attempted case
- Adult participants gave the system a 91% ease-of-use rating
- The user error rate was below 1%
In April 2025, IKE Tech submitted the first standalone component premarket tobacco product application (PMTA) in the U.S. for an interoperable age-verification technology. The FDA accepted the application for review in 2025, and the review is ongoing. Acceptance for review is not a marketing authorization.
This study has not been peer-reviewed. Results from controlled testing do not guarantee identical outcomes in real-world use.
The study is registered on ClinicalTrials.gov under identifier NCT06952569.
View the study record on ClinicalTrials.gov →