For over a decade, the safety profile of mandibular advancement devices (MADs)—the oral appliances prescribed to treat obstructive sleep apnea (OSA)—was remarkably consistent. Practitioners and regulators alike viewed these devices as low-risk interventions, with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database showing a stable, predictable trickle of adverse event reports.
However, a recent retrospective analysis published in the Journal of Clinical Sleep Medicine has shattered that perception. In 2024 and 2025, researchers identified a 10.1-fold increase in adverse event reports compared to the previous four-year average. This statistical spike has ignited a debate within the dental sleep medicine community: Does this represent a legitimate decline in device safety, or is it merely an artifact of improved regulatory compliance and evolving data collection methods?
The Catalyst: An Unexpected Discovery
The investigation began not in a high-level government laboratory, but during the routine academic preparations of two dental sleep specialists. Sue Ellen Richardson, DDS, DABDSM, FAASM, and Aaron Glick, DDS, FICOI, FAGD, DABDSM, were curating a webinar presentation on FDA regulatory status when they accessed the MAUDE database.
"I was going to point out that the MAUDE database was characteristically very, very small for oral appliances compared to many other treatments for OSA," says Richardson, clinical director at Houston Sleep Well. "And then I was like, ‘What in the world?’"
What they found was a seismic shift in reporting volume. Between 2013 and 2023, the MAUDE database recorded a mean of just 41 adverse event reports annually. The data was so sparse that it was rarely used as a barometer for industry trends. The 2024–2025 figures, however, showed an average of 423.5 reports per year, with 2025 alone recording 662 individual submissions.
Chronology of the Reporting Shift
To better understand the phenomenon, Glick and Richardson categorized their findings into two distinct temporal cohorts:
- Period A (2020–2023): This period represented the "baseline" of the modern era, characterized by an average of 42.0 reports per year. The predominant reports during this window—approximately 78%—centered on biocompatibility, such as allergic reactions to materials or skin irritation. Only 8.9% of reports involved structural failure or device fractures.
- Period B (2024–2025): The data profile underwent a total transformation. Mechanical failures became the new norm, accounting for 91.6% of all entries. Conversely, allergy-related reports plummeted to a mere 4.8%.
This "fundamental shift," as the researchers describe it, suggests that the nature of what is being reported to the FDA has changed as much as the frequency. The primary point of failure transitioned from the patient’s biological response to the device to the physical integrity of the device itself.
Supporting Data and the "Denominator" Problem
Despite the alarming raw numbers, both researchers and industry experts caution against interpreting these figures as a direct indicator of increased clinical risk. The primary hurdle in interpreting MAUDE data is the absence of a "denominator"—the total number of devices currently in use across the United States.
"We don’t know how many devices were in use during that period, so we can’t determine true incidence," Richardson explains. "What we can say is that it is unusual to see such a marked change over such a short period of time."
The FDA explicitly states that MAUDE is a passive surveillance system, not a clinical registry. It is subject to significant reporting bias; companies with rigorous internal compliance departments are naturally more likely to flood the database with reports than smaller dental labs that may lack the infrastructure for systematic, continuous post-market surveillance.
Manufacturer and Provider Responses
The study identified that one specific product line—the Silent Nite device, manufactured by Prismatik Dentalcraft—accounted for 97.6% of the reports in the high-volume Period B.
Shelly Gallup, senior vice president of regulatory affairs and quality assurance at Prismatik Dentalcraft, argues that the surge is a result of internal process optimization rather than product decline. "The increase in MAUDE reports beginning in 2024 is primarily attributable to changes in how Prismatik captures and processes complaints, including centralized intake and expanded internal review," Gallup stated.
Gallup emphasizes that Prismatik operates under strict adherence to 21 C.F.R. Part 803. She notes that many competitors, which function primarily as small dental laboratories, do not necessarily face the same level of federal scrutiny or possess the resources to manage such extensive complaint-processing systems. By reporting even minor hinge fractures that do not cause patient injury, Prismatik’s transparent approach effectively inflates its own footprint in the MAUDE database compared to rivals who may be under-reporting.
The Telehealth Factor
The emergence of direct-to-consumer (DTC) telehealth models has further complicated the data landscape. The study identified 42 reports linked to DTC models, with the company Daybreak accounting for 92.9% of that subset.
Peter Balacky, DDS, dental director at Daybreak, challenges the narrative that these figures represent a failure of the telehealth model. "The direct-to-consumer subcategory the authors highlight comprises only 42 of the 1,015 total reports reviewed—about 5% of the full dataset," Balacky notes.
Daybreak contends that their proactive, digital-first model actually results in higher reporting rates because they maintain constant, documented contact with patients. "We report every qualifying event on a monthly cadence, an obligation individual dental practices generally don’t carry," Balacky adds. "That’s a function of compliance, not elevated risk."
Clinical Implications: A Disconnect from Literature
One of the most intriguing findings of the study is the disconnect between the MAUDE data and established clinical literature. Academic journals frequently discuss side effects like permanent bite changes, temporomandibular joint (TMJ) discomfort, and periodontal issues. Yet, these are virtually absent from the MAUDE database.
This suggests a "filtering" effect:
- Clinical Management: Dentists in private practice are highly skilled at managing side effects like jaw soreness or tooth movement during routine follow-up appointments. Because these issues are corrected in the office, they rarely rise to the level of an FDA-reportable adverse event.
- Reporting Bias: Mechanical failures—such as a snapped hinge—are binary, visible, and easy to document. They are far more likely to trigger a report than a patient’s subjective report of "jaw ache," which is harder to quantify and attribute definitively to the device.
Moving Toward Better Surveillance
The consensus among researchers and stakeholders is that while the MAUDE spike is not a call to abandon oral appliance therapy, it is a clarion call for better data. Oral appliances remain a gold-standard, safe, and effective treatment for obstructive sleep apnea.
"Mandibular advancement devices are very safe and effective," says Dr. Glick. "That shouldn’t dissuade anyone from continuing to prescribe or use these devices."
However, the field of dental sleep medicine is at a crossroads. As manufacturing shifts toward 3D printing and digital workflows, and as care delivery moves from the physical chair to the virtual portal, the mechanisms for monitoring patient safety must evolve.
Recommendations for the Future:
- Establishment of Registries: The industry needs a formal, standardized clinical registry that includes denominator data (total devices sold/active) to calculate true event rates.
- Standardized Reporting Definitions: As seen with the Prismatik case, the definition of an "adverse event" can vary wildly between a major corporation and a small lab. The FDA may need to provide more specific guidance for the dental appliance sector.
- Continuing Education: Dentists must remain vigilant in their follow-up care, as their direct oversight is the ultimate safeguard against the side effects that never make it into the FDA’s databases.
Ultimately, the 2024–2025 spike in reports is likely a snapshot of a maturing industry, one that is becoming more transparent, more digitized, and more heavily scrutinized. For the patient, this transition toward rigorous reporting—even if it looks like a "safety flag"—is a necessary step toward ensuring that oral appliances remain a trusted, reliable, and evidence-based solution for the millions suffering from obstructive sleep apnea.
