Letter 1, Issue 13.2

Response, “Electronic MADs in DSM: Promise, Questions, and Responsibilities.”

http://dx.doi.org/10.15331/jdsm.7444
 
Dear Dr. Masse,

Thank you for your editorial, “Electronic Mandibular Advancement Devices in Dental Sleep Medicine: Promise, Questions, and Responsibilities in a New Technological Era.”¹ Your thoughtful reflections on the integration of electronic sensors into oral devices raise important questions about data privacy, clinical utility, and the ethical stewardship of innovation.

ProSomnus shares your commitment to patient-centered care and evidence-based practice. We recognize the importance of demonstrating data security, integration into clinical workflows, and long-term value. And, it should be noted, device regulators require it. The ProSomnus sensor device was developed in alignment with applicable FDA, Health Canada, and international regulatory guidance and relevant ISO standards, including ISO 13485 (quality management) and ISO 14971 (risk management).
 
Evidence-Based Innovation

The ProSomnus sensor device was developed to address a well-established gap in sleep medicine: the need for accurate, multi-night monitoring of arterial oxygen saturation (SpO₂) in a comfortable, patient-friendly format. Research conducted at the University of Calgary, which was subsequently published in a peer reviewed medical journal, found that the ProSomnus sensor device generated accurate data, with a root mean square error of 2.94% for SpO₂ and 2.08 bpm for pulse rate across a wide range of hypoxemia.

The research also concluded that the buccal mucosal site offers several advantages over conventional oximetry locations: it is highly vascular, temperature-stable, shielded from ambient light, and less affected by melanin variability. These features contribute to the device’s reliability and comfort, making it suitable for long-term and multi-night use. These results support the device’s utility.

Data Privacy: A Broader Perspective
 
We welcome your call for clarity around data privacy and security. However, it is worth asking why similar concerns have not been raised for other technologies widely used in sleep medicine?

Home sleep apnea testing devices routinely collect sensitive physiologic data—oxygen saturation, respiratory effort, body position—and transmit it to cloud-based platforms. Many of these devices generate personal health data often processed by third-party vendors or stored in proprietary systems. In-laboratory polysomnography also generates extensive patient health data, yet transparency around data handling, patient consent, and long-term storage practices is often limited.

As you rightly note, the issue is not whether smart oral devices are uniquely risky, but how they fit into a broader ecosystem of digital health tools. We believe this is an opportunity for the profession to establish consistent standards across all sleep technologies—whether wearable, nearable, in-laboratory, or home-based, including smart oral devices, CPAP machines, and surgically implanted devices.

Commitment to Privacy and Security

ProSomnus has taken proactive steps to align with leading data privacy frameworks, including HIPAA and the EU-US Data Privacy Framework, which together reflect US and international standards. ProSomnus is one of the only sleep medicine companies, for example, to conform with, qualify for, and register with the EU-US Data Privacy Framework (https://www.dataprivacyframework.gov/list). Data collected by our device are encrypted, stored securely, and accessible only to authorized users.

ProSomnus is committed to publishing clear documentation on what data are collected and how these data are processed. We are also committed to conducting medical-grade research that validates use cases for the data. We welcome collaboration with the American Academy of Dental Sleep Medicine, and other stakeholders, to establish best practices for consent, data use, and integration into care pathways.

During the open forum session at the most recent American Academy of Dental Sleep Medicine annual meeting in Las Vegas, I made a similar call for consensus on smart oral devices. Although my comments were acknowledged, ProSomnus has not received follow-up. It is worth mentioning that ProSomnus has routinely engaged several dozen leading dental sleep medicine physicians and sleep medicine physicians in the design, development, and continuous improvement of our sensor device program.

In closing, we thank you and the Journal of Dental Sleep Medicine editorial team for fostering this conversation. ProSomnus believes that with transparency, collaboration, and a shared commitment to excellence, smart oral devices have the potential to enhance the quality and personalization of dental sleep medicine—and be a catalyst for broader, long-overdue conversation about selecting the optimal therapy for each individual patient with OSA.

CITATION

Liptak, L. Response, “Electronic MADs in DSM: Promise, Questions, and Responsibilities.” J Dent Sleep Med. 2026;13(2).

REFERENCES

1. Masse, JF. Electronic mandibular advancement devices in dental sleep medicine: Promise, questions, and responsibilities in a new technological era. J Dent Sleep Med. 2025;12(4).

SUBMISSION AND CORRESPONDENCE INFORMATION

Submitted for publication October 30, 2025
Accepted for publication February 4, 2026

Address correspondence to: Len Liptak, BA, MBA, PLD; Email: lliptak@prosomnus.com

DISCLOSURE STATEMENT

Len Liptak is CEO for ProSomnus Sleep Technologies.

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