By Sree Roy

Though the technology to make oral appliances “smart”—embedding them with data-transmitting sensors and even enabling auto-titration for sleep position and stage variability—has existed for more than a decade, a flurry of recent activity in the space has sleep professionals curious about factors fueling the renewed enthusiasm.

Smart oral appliances in development include the RPMO2 from well-known manufacturer ProSomnus, a photoplethysmography (PPG)-based sensor from startup Dianyx Innovations (developed by a neurologist-sleep physician), and novel designs from new entrant Achaemenid Innovations LLC, spearheaded by a dentist, including a self-titrating, tongue-focused potential oral appliance add-on. Slow Wave Sleep, a company that markets bruxism and sleep apnea oral appliances, has an auto-titrating oral appliance in clinical trials. Meanwhile, dental behemoth Glidewell’s acquisition of ORB Innovations facilitated its launch of smart sports mouthguards, and the company says entry into the smart sleep appliance market will be next. 

What’s propelling these medical technology developers? Their case for smart oral appliances is attuned to these trends:

• the surge in consumer physiological tracking devices (such as the Apple Watch and Oura Ring);
• the growing acceptance of remote patient monitoring reimbursement (RPM) codes; and
• an opportunity to fill in the disconnect in sleep medicine between dentists and physicians.

History of Smart Oral Appliances

Richard A. Bonato, PhD, RPSGT, probably has more experience in the smart oral appliances market than anyone else in sleep medicine. As founder and CEO of BRAEBON, he spearheaded the launch of the DentiTrac micro-recorder in the United States in 2015 and has overseen several updates—such as enhanced cloud software, reporting, and hardware—over the past decade.  

DentiTrac only transmits data about compliance—that is, whether the person uses their oral appliance—and Bonato doesn’t seem to be in a rush to add bells and whistles, such as PPG or electroencephalography (EEG), to it. While Bonato concedes that additional sensors would give people the ability to measure effectiveness in addition to compliance, he says, “There are companies out there trying to throw everything, including the kitchen sink, into the design. That just adds more complexity, and it adds more questions. Yes, you can do it. Should you do it? That’s a question for every company to decide.”

For now, the main market for DentiTrac smart oral appliances is the transportation industry, according to Bonato. But that window of opportunity is closing. “When we have self-driving cars, taxis, and commercial trucks, that’s really going to impact this market,” he says. “Let’s say 50% of the market goes away. That’s going to be a threat.”

Neurologist-sleep physician Asim Roy, MD, co-founder of Dianyx Innovations, sees the market somewhat differently. Dianyx, which exhibited its investigational PPG-based sensor at CES 2025, expects access to a sleep apnea patient population of 70,000 across the United States after the device receives US Food and Drug Administration (FDA) clearance. “As we’ve been developing the product, we’ve been connecting with different sleep clinics, telehealth companies, and transportation companies, and many of them have signed a letter of intent that they would be a customer upon commercialization,” Roy says. Other up-and-coming smart oral appliance manufacturers have similarly high expectations.

Trend #1: Rise of Consumer Physiological Tracking Devices

Stephenie Goddard, CEO of dental device and services company Glidewell, sees many opportunities for smart oral appliances. “There’s a reason why people are buying Oura Rings, Apple Watches, Garmins, and everything else, right? They want to have more data, and the more information you have about your overall health, you can possibly make proactive changes,” she says.

In the fall of 2024, Glidewell launched smart mouthguards for athletes in contact sports, made possible by its acquisition of ORB Innovations, a developer of technology that measures wearers’ physiological and biomechanical activities within an oral appliance. 

According to David Leeson, Glidewell’s head of engineering, data gleaned from smart oral appliances can prove more useful than that offered by consumer trackers. In the case of smart mouthguards, for example, Glidewell is “measuring up to 200G, which is outside of the normal consumer range, for head impacts. And the bandwidth we’re measuring is many orders of magnitude higher than you would do for other physiological applications,” he says.

Next on Glidewell’s roadmap are smart sleep appliances. “We want to focus where we can add unique value from an oral appliance and not just duplicate what’s available by existing products,” Leeson says. “There are many times where there are the beginnings of an event, or a small event, that current technology really can’t measure. And we’re seeing some opportunity to be able to measure those things with a greater level of sensitivity and without that latency.”

Measuring sleep-breathing parameters from within the mouth has inherent strengths, according to Dianyx’s Roy. “If you have a sensor on your finger or on your wrist, there’s a lot of artifact that can happen,” Roy says. But in the mouth, “it’s a dark environment, so the light pollution is less. This [sensor] is fixated onto a dental device, so there’s less motion artifact. And inside the mouth is much more similar across different ethnicities than the outside [is].” Roy adds, however, that “these are all things we need to validate.”

ProSomnus Sleep Technologies has started the validation work on the investigational RPMO2 smart device. “We have performed matched pair accuracy tests against blood gas samples and FDA-cleared reference oximeters during controlled desaturation experiments between 100% and 70% desaturation. These tests demonstrate RMSE [root-mean-square deviation] values of 2.32%, favorable to the established target of 3.5% RMSE,”¹ says Len Liptak, CEO and director of ProSomnus. “We are aiming for proper medical-grade validation and doing the clinical, medical, scientific, and technological work to support this goal.”

Data captured from these devices can help shift the field of sleep medicine from frequency metrics (such as the apnea-hypopnea index [AHI] and respiratory disturbance index) to risk metrics, like hypoxic burden² and pulse rate variability, that have scientifically demonstrated predictive values, Liptak says.

It also could shift the expectations for therapy goals. The three to six months before the patient undergoes a sleep study to confirm an oral appliance’s efficacy (or to further titrate it) could become three to six weeks instead.

While waiting for a sleep study, sleep apnea patients with oral appliances can easily be “untreated or undertreated,” says Reza Radmand, DMD, FAAOM, the dentist-founder of Archaemenid Innovations LLC, which is developing smart oral appliances. “But if you can help them get from point A to point B as soon as possible, knowing whether that appliance is either working, or getting them into something that actually works, with an objective mechanism to validate whether that therapeutic modality is working, it could be a cost savings, not an expense.”

Trend #2: Growing Acceptance of RPM Codes

RPM reimbursement has been much hyped in sleep medicine, but the financial payoffs vary based on payor and diagnosis. Still, many see RPM reimbursement codes as the likely venue for recovering any extra costs associated with smart oral appliances. 

“These codes are currently reimbursed by most payors, definitely by CMS [Centers for Medicare & Medicaid Services],” neurologist-sleep physician Roy says. “And the generated revenue goes to the healthcare provider.” Dianyx’s fee for managing the software and data would only be a fraction of the RPM reimbursement the physician would earn, he says.

But others caution against reliance on an RPM model. Long-time sleep industry participant Robin Randolph, whose previous employment includes positions at ResMed and Fisher & Paykel and who is currently vice president of sales at oral appliance marketer Good Sleep Co, says that long ago she believed RPM codes would persuade physicians to monitor their patients’ CPAP downloads. But “$60 wasn’t enough to incentivize a very busy primary care doc or sleep doc to monitor,” she says. “But they liked the idea of monitoring, and guess who monitored? The DME [durable medical equipment supplier] accepted the monitoring to get the orders. I can see that happening here too.”

Trend #3: Filling the Disconnect Between Dentists and Sleep Physicians

These devices will make it easier for sleep physicians to maintain their connection with patients, many smart oral appliance developers say. “Physicians often note that they lose track of the patient when they refer them to dentists, respiratory therapists, or surgeons for treatment,” ProSomnus’ Liptak says. “The monitoring data from these devices can alert the healthcare provider to emergent issues that might justify ordering a diagnostic test or scheduling a follow-up medical evaluation to address emergent issues. 

“The data from these devices may be used to transition follow-up appointments from subjective discussions to evidence-based discussions.”

While physicians will be the ones discussing the smart oral appliance data with patients, dentists will win too, Roy says. “The goal is to drive more engagement,” he says. “Oral appliances have been on the market for 20- or 30-plus years, and the growth of oral appliances is nowhere near the growth of CPAP. We think this kind of data and technology will help drive more patients to this therapy.”

Randolph, for one, hopes that if more patients are driven to smart oral appliance therapy that it’s only after the industry applies the lessons learned from making “smart” CPAPs. “What I don’t want to happen—that happened before—is penalizing the patient,” she says. For instance, with the evidence from their built-in sensors, CPAPs are taken away from patients who don’t meet a payor-determined usage threshold. 

While it seems unlikely that a custom device would be removed from a patient, payors could, for instance, spread the reimbursement fee over a longer time and make it contingent on usage thresholds. “The payors will need to adopt a more nuanced approach to prioritize collaboration of care,” Randolph says. “In their policies, they need to ensure that there is discussion going on between the care providers—a collaboration of care between physicians, dentists, and the patient.”

Will We Ever Get an ‘APAP’ for Oral Appliances?

Once therapeutic devices can gather data, their developers have the potential to use that data to develop algorithms that personalize therapy settings. That begs the question: Will smart oral appliances lead to auto-adjusting oral appliances that titrate themselves breath by breath, similar to auto-adjusting positive airway pressure devices (APAPs)?

Proof-of-Concept

Surprisingly, a proof-of-concept for an auto-adjusting mandibular repositioning device for in-home use existed a decade ago. It consisted of an electronic sensing platform that included a wireless finger-worn pulse oximeter and chest-worn accelerometer to detect disordered breathing events during sleep, as well as a soft robot pneumatic actuator that changed the jaw position. It worked pretty well.³

“We did not go forward because we could not find a company…that was looking to invest in the research and development that would be needed to bring the device to market,” says Gregory Essick, DDS, PhD, DABDSM, an adjunct professor at the Adams School of Dentistry at the University of North Carolina – Chapel Hill, who worked with graduate students on the system.

And while he likes the APAP analogy, Essick says it isn’t completely accurate. “The relationship between the jaw position and the AHI is more complex than the relationship between air pressure and AHI,” he says. For instance, in a significant number of people, there is a point beyond which, if the appliance continues to be advanced, the patient’s AHI will actually begin to increase. “The relationship between jaw advancement and AHI is non-linear and can be quite complicated,” he says.

So while the proof-of-concept auto-adjusting setup did not change jaw position as quickly as an APAP changes pressure, it could—based on the stage of sleep and perhaps data from previous nights—adjust the patient’s jaw both reactively in response to objective respiratory signals and predictively in response to changes in sleeping position, according to Essick.

Essick is excited to see renewed interest in smart oral appliances. “This technology was available 10 years ago, easily,” he says. “It’s great we’re finally moving in that direction.”

Achaemenid Innovations

Dentist Radmand is certainly moving in that direction. The Achaemenid Innovations team has created functional prototypes of “iNOS,” an intraoral oximeter that quantifies the severity of sleep apnea-related hypoxemia,⁴ a wireless intraoral EEG device, and a tongue stimulator with a microprocessor that could use iNOS data to adjust frequency and current.

The investigational auto-titrating tongue stimulator, designed to curl the tongue and bring it down posteriorly to open space in the back of the throat, could become a combination therapy used with an oral appliance. By moving the tongue out of the way, it may lessen the protrusive position required from a mandibular advancement device (MAD). “The hypothesis is if we combine that with the MAD, we could be very close to getting almost 100% efficacy of the appliance,” Radmand says. “We also will likely be able to reduce any potential myofascial side effects of our conventional MAD.”

Slow Wave Sleep

Slow Wave Sleep, marketers of the Slow Wave DS8 oral appliance that is dual FDA-cleared for sleep apnea and bruxism, also wants to get the tongue out of the way. “We have more space with less vertical movement…because we don’t cover the tips of the teeth,” says Slow Wave Sleep CEO Wayne Wagner. That is, without an extra millimeter of oral appliance material added to each tooth tip, an 8 mm opening on a Slow Wave DS8 means the tongue has 8 mm to get into its resting position versus only 6 mm (subtracting 1 mm each for oral appliance material on top and bottom) on some other oral appliances designs at the same 8 mm opening.

More intriguingly, Slow Wave Sleep is testing an auto-titrating version of the DS8 in a 70-person clinical trial at Austin Heart in Central Texas. But the “smart” sensor used to gather data to adjust jaw position based on oxygen levels isn’t embedded in the oral appliance. “The sensor is your brain,” Wagner says.

Based on the idea that the brain naturally maneuvers the jaw to facilitate breathing during sleep (sometimes manifesting as sleep bruxism), Slow Wave Sleep designed a 3D-printed sliding ramp as a titration device in its oral appliance. “So the more you grind, the more you’re going to drift forward, and your subconscious is going to find the spot where you breathe the best,” Wagner says. “We’ve made the ramp infinitely variable, forward and back, right and left, so as you grind, the ramp slides.” (The clinical trial will use a PPG-based ring to confirm participants’ oxygen levels.) 

Wayne thinks this self-adjusting (but not data-transmitting, at least in its current iteration) device will resolve any concerns about night-to-night or sleep position-to-position variations in AHI for oral appliance users.

Smart Oral Appliances, Smart Outcomes?

Smart oral appliances may be available to sleep apnea patients within the next two years. But will they catch on this time? Should they?

Ultimately, the emphasis of new oral appliance technology should be on ensuring it truly benefits the patient, according to Randolph. She hopes payors and manufacturers prioritize patient education and dentist-physician-patient collaboration, ensuring that patients receive the same, or improved, care. After all, she says, “It’s supposed to be about outcomes.”

References

1. Mosca E, Lai ML, Di Simone G, et al. An oximeter embedded in a precision oral appliance therapy device can accurately and continuously monitor SPO2. CHEST. 2024 Oct;166(4):A6542-3.
2. Mosca E, Grosse J, Remmers JE. Validation of an O2 Event-Triggered Sleep Apnea-Specific Hypoxic Burden Calculator Using a Novel Method for Approximating Baseline Oxygen Saturation. CHEST. 2024 Oct;166(4):A6533.
3. Brugarolas R, Valero-Sarmiento JM, Bozkurt A, Essick GK. Auto-adjusting mandibular repositioning device for in-home use. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:4296-9.
4. Vena D, Esmaeili N, Radmand R, et al. Intraoral pulse oximetry to quantify sleep apnea related hypoxemia: proof of principle. Sleep Med. 2024;115(Suppl 1):S361.

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