The MAUDE database is the FDA’s primary passive surveillance system for medical device problems. Manufacturers, importers, and user facilities are required to submit reports of device-related deaths, serious injuries, and malfunctions, while the public and health professionals may file voluntary reports. Because it aggregates real-world experience across thousands of dental sleep medicine practices, it offers a view of device safety that clinical trials, which typically follow small cohorts for limited periods, cannot match. Glick and Richardson analyzed this publicly available database to identify adverse event reports associated with oral appliances used for sleep-disordered breathing, and to examine how the categories of reported harm have trended across the reporting period.

Oral appliance therapy, in its most common form, uses a mandibular advancement device: a two-arch dental appliance that holds the lower jaw forward during sleep, tightening the upper airway and reducing collapse that drives apneic events. The approach is endorsed in clinical practice guidelines from the American Academy of Sleep Medicine and the American Academy of Dental Sleep Medicine as a legitimate therapy for patients with obstructive sleep apnea, particularly those who are intolerant of CPAP or prefer an alternative. Recent studies cited in the letter underscore why the therapy has gained ground. One 2025 analysis found that oral appliance therapy is highly efficacious at reducing sleep apnea-specific hypoxic burden, a metric predictive of cardiovascular morbidity and mortality. Another 2026 study comparing long-term outcomes of mandibular advancement devices with CPAP found meaningful therapeutic efficacy in patients with obstructive sleep apnea, reinforcing the devices’ clinical standing.

Yet the same mechanism that makes these appliances effective, mechanically protruding the mandible night after night for years, is also the source of their characteristic side effects. The dental sleep medicine literature has long catalogued a spectrum of harms: temporomandibular joint discomfort, myofascial pain, dental pain, occlusal changes in which the bite shifts as teeth move under sustained force, dry mouth, hypersalivation, and gum irritation. A 2025 systematic review and meta-analysis comparing side effects across different mandibular advancement devices found that these effects are common and vary by device design, a point that matters because the market now includes a wide range of custom, semi-custom, and over-the-counter products. The American Academy of Dental Sleep Medicine has published recommendations for managing these side effects, emphasizing monitoring and follow-up as integral parts of therapy rather than optional extras.

Against that backdrop, the rising volume of adverse event reports in MAUDE is a signal that cannot be dismissed as statistical noise, even though passive reporting systems carry well-known caveats. Report counts in such databases are influenced by many factors beyond true incidence: the size of the exposed population, growing awareness among clinicians and patients that reporting is possible, expanded marketing of oral appliances, and the rise of teledentistry pathways that deliver dental sleep medicine with fewer in-person touchpoints. The letter’s authors note the growth of teledentistry in dental sleep medicine as an innovation that requires safeguards, a nod to the possibility that remote care models, while expanding access, may change how side effects are detected, managed, and reported.

The second half of the finding, the shifting categorical trends, is arguably the more consequential one. When the composition of adverse event reports changes over time, it can indicate that the nature of device use is changing, that new device designs are introducing new failure modes, or that the patient population receiving appliances is evolving. Prior work on the MAUDE database has already explored this terrain: a 2025 analysis in Respiratory Medicine examined adverse events associated with mandibular repositioning appliances specifically, establishing that the database contains enough signal to support categorical analysis. By updating and extending that picture, Glick and Richardson provide dental sleep medicine clinicians with a current map of where reported harms are concentrating, information that can guide the follow-up questions dentists ask and the monitoring protocols they adopt.

For patients, the practical message is that oral appliance therapy is not a set-and-forget intervention. Dental sleep medicine standards published in 2025 for screening, treatment, and management of sleep-related breathing disorders in adults using oral appliance therapy stress that therapy begins with proper screening and diagnosis, continues with device fitting and titration, and depends on ongoing surveillance of both efficacy and side effects. The side effects documented in the literature, particularly the dental and skeletal changes that can accrue silently over years of use, are precisely the kind of harm that a patient sleeping alone with a remote provider may not notice until the bite has shifted. Regular in-person evaluation of the bite, the temporomandibular joints, and the airway response remains a cornerstone of safe therapy.

The study also arrives at a moment when the dental sleep medicine field is professionalizing rapidly. More dentists are seeking certification, more primary care physicians are referring patients who cannot tolerate CPAP, and more consumers are encountering oral appliances through advertising and direct-to-consumer channels. Each of these trends enlarges the population of device users, and each carries implications for the adverse event reporting stream. A database like MAUDE cannot by itself separate increased use from increased risk, which is why the authors’ framing of increasing reports alongside shifting categorical trends is careful: it documents what is being reported and how the pattern changes, rather than claiming a precise incidence rate that passive surveillance cannot deliver.

That limitation is worth stating plainly, because it defines what the study can and cannot tell the public. MAUDE reports are voluntary in part, unverified in most cases, and subject to duplicate, incomplete, and delayed submissions. The FDA itself cautions that the database cannot be used to calculate incidence. What it can do, and what this research letter does, is reveal the shape of the harm landscape: which categories of adverse events are appearing, whether reports of temporomandibular disorders, dental changes, or other complications are growing relative to one another, and whether the overall reporting trajectory is climbing. For a therapy whose user base is expanding and whose delivery models are changing, that shape is exactly the information clinicians, device designers, and regulators need to prioritize.

The authors, who analyzed the data jointly and drafted the manuscript together, report no funding for the work; Richardson discloses no conflicts of interest, while Glick discloses an ownership stake in Ember Sleep and consultancy work for the American Academy of Dental Sleep Medicine, disclosures that are relevant context for readers weighing the letter’s conclusions. The study was received in April 2026, revised in June, accepted on 1 July, and published on 22 July 2026 in the journal’s volume 22 as article number 121. Its brevity, a research letter rather than a full study, reflects the nature of the evidence base: a public database, a categorical analysis, and a clear signal that warrants prospective research. For the millions of patients who wear a mandibular advancement device every night, and for the dentists who fit them, the takeaway is not alarm but vigilance. Oral appliance therapy remains a guideline-endorsed, increasingly evidence-supported treatment for obstructive sleep apnea. The rising and shifting adverse event reports in the FDA’s own surveillance data are a reminder that its safety depends on the follow-up that happens after the appliance leaves the dental chair.

Subject of Research: Adverse event reporting trends for oral appliances used in obstructive sleep apnea therapy

Article Title: Increasing reports and shifting categorical trends in adverse events for oral appliances

Article References: Glick, A., & Richardson, S. E. (2026). Increasing reports and shifting categorical trends in adverse events for oral appliances. Journal of Clinical Sleep Medicine, 22(1), Article 121. https://doi.org/10.1007/s44470-026-00139-y

Image Credits: AI Generated

DOI: 10.1007/s44470-026-00139-y

Keywords: oral appliance therapy, obstructive sleep apnea, MAUDE database, adverse events, mandibular advancement devices, dental sleep medicine, temporomandibular disorders, FDA surveillance, teledentistry, CPAP alternatives, side effects, sleep disorders

The letter, written by Nashmia Faraz, Haider Imran and Abdul Basit of the Department of Medicine at Foundation University Medical College in Islamabad, Pakistan, takes aim at the gap between objective and subjective measures of adherence in oral appliance therapy. Published in September 2026, the correspondence responds to emerging longitudinal evidence on how adults with obstructive sleep apnea actually use their appliances over a full year, and it argues that the field must refine how adherence is defined, measured and interpreted before the therapy’s real-world effectiveness can be judged fairly.

The concern is not academic hair-splitting. An oral appliance that sits in a drawer delivers no therapeutic benefit, no matter how well it was designed or how effectively it advanced the jaw in a laboratory titration study. Adherence is the hinge on which the entire treatment turns. For CPAP, this lesson was learned early and painfully: studies famously showed that early patterns of use in the first days and weeks strongly predicted long-term adherence, prompting sleep medicine to invest heavily in objective compliance monitoring, telehealth coaching and early intervention programs. Modern CPAP machines log every hour of use, and those data streams are now woven into routine care. Oral appliance therapy, by contrast, has largely depended on what patients report at follow-up visits.

Self-report is a notoriously fragile foundation for clinical decisions. Patients may genuinely believe they wear their devices more than they do, because nights of fragmented sleep blur memory and because social desirability nudges people toward the answers they think their clinicians want to hear. The literature cited in the letter makes the scale of the discrepancy unmistakable. A landmark 2013 study published in Chest by Dieltjens and colleagues compared objectively measured compliance, captured by embedded microsensors, with self-reported compliance among patients using mandibular advancement devices for sleep-disordered breathing. The objective data revealed substantially lower usage than patients reported, exposing a gap large enough to distort outcome studies, cost-effectiveness analyses and clinical audit alike.

Embedded microsensors have since become the technical benchmark for objective adherence measurement in oral appliance therapy. These tiny temperature-sensitive chips sit inside the appliance and register when the device is actually in the mouth, distinguishing genuine use from mere possession. When the appliance is inserted, oral temperature triggers the sensor; when it rests on a bedside table, no temperature change is recorded. The approach mirrors the objective compliance chips that transformed CPAP monitoring, and it offers sleep medicine something it has long lacked for dental devices: a truthful, time-stamped record of real-world use patterns, including how many nights per week the appliance is worn and for how many hours per night.

The new longitudinal pilot data that prompted the letter tracked both objective and subjective adherence in adults with obstructive sleep apnea over one year, providing a rare window into how usage evolves well beyond the initial adaptation period. The corresponding letter argues that such data should push the field toward a more nuanced adherence framework, one that distinguishes between objective device use, patient-perceived use and clinical response, rather than collapsing them into a single self-reported figure. The authors, who conceptualized and drafted the correspondence with no external funding and no competing interests, position their contribution as a call to tighten the methodological standards of oral appliance research.

Why does this refinement matter now? Oral appliance therapy is expanding rapidly. Clinical guidelines recommend it for patients with mild to moderate obstructive sleep apnea and for those with severe disease who cannot tolerate or decline CPAP. Dental sleep medicine has grown into a distinct subspecialty, and the global market for mandibular advancement devices continues to climb as obesity rates and disease prevalence rise. Every prescription implicitly assumes that the device will be worn consistently. If adherence measurement lags behind prescription volume, the field risks both overtreatment, with devices dispensed to patients who will never use them, and undertreatment, with genuine adherence problems overlooked until symptoms return or cardiovascular risk quietly accumulates.

The letter also draws an instructive parallel with the CPAP literature, including the 2007 study by Budhiraja and colleagues in the journal Sleep demonstrating that early CPAP use identified subsequent long-term adherence. That finding reshaped clinical practice, motivating early follow-up and, eventually, remote monitoring programs that flag struggling patients within days. For oral appliances, the analogous evidence base is younger and thinner, but studies such as the 2022 investigation by Kwon and colleagues in the Journal of Sleep Research show that remote monitoring and structured feedback can measurably improve objective compliance with mandibular advancement devices. Together, these strands of evidence suggest that objective adherence measurement is not merely a research nicety; it is the enabling technology for the same kind of proactive, data-driven care that rescued CPAP adherence a generation ago.

The technical challenges, however, are real. Microsensor data must be validated against true wear events, sensors can fail or be damaged during cleaning, and different sensor generations may not produce comparable metrics. The field lacks universally accepted adherence thresholds for oral appliances, whereas CPAP benefited from widely used conventions such as the Medicare definition of four hours per night on seventy percent of nights, itself a contested standard. Without consensus definitions, meta-analyses of appliance effectiveness will continue to mix studies whose adherence figures mean different things, blurring genuine differences in therapeutic efficacy with differences in measurement practice. The authors of the letter imply that resolving this definitional tangle is a prerequisite for the next generation of oral appliance research.

What would refined adherence assessment look like in practice? The ingredients are already on the table: objective sensor-derived metrics reporting nights and hours of use, patient-reported measures captured with validated questionnaires, and clinical outcomes such as the apnea-hypopnea index on follow-up polysomnography or home testing. Longitudinal designs, like the one-year pilot study that sparked the correspondence, add the crucial temporal dimension, revealing whether adherence decays over months and which patients are at greatest risk of abandoning therapy. Integrating these data streams into electronic health records and telemedicine platforms could finally give dental sleep medicine the feedback loops that clinicians need, allowing early, targeted interventions before non-adherence becomes entrenched. As oral appliance therapy takes its place alongside CPAP in mainstream sleep medicine, the message from Islamabad is clear: the therapy can only be as good as the evidence that patients are actually using it, and measuring that use honestly is the field’s next essential task.

Subject of Research: Objective versus subjective adherence assessment in oral appliance therapy for obstructive sleep apnea

Article Title: Refining adherence assessment in oral appliance therapy for obstructive sleep apnea

Article References: Faraz, N., Imran, H., & Basit, A. (2026). Refining adherence assessment in oral appliance therapy for obstructive sleep apnea. Journal of Clinical Sleep Medicine, 22(1), Article 158. https://doi.org/10.1007/s44470-026-00176-7

Image Credits: AI Generated

DOI: 10.1007/s44470-026-00176-7

Keywords: obstructive sleep apnea, oral appliance therapy, mandibular advancement device, adherence measurement, microsensors, CPAP, sleep medicine, self-reported compliance, remote monitoring, dental sleep medicine, Journal of Clinical Sleep Medicine, Refining