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Sleep Medicine

(029) An FDA MAUDE Database Analysis of OSA Treatment Devices

Monday, October 2, 2023
2:45 PM – 3:45 PM East Coast USA Time
Has Audio

    Presenting Author(s)

  • Edward Sall, MD, DDS, MBA

    Medical Director
    ProSomnus Sleep Technologies and Advanced ENT Physicians of CNY
    Fayetteville , New York, United States

    • Co-Author(s)

  • LL

    Len Liptak, MBA

    ProSomnus Sleep Technologies, USA

    • Senior Author(s)

  • MM

    Mark T. Murphy, DDS

    Lead Faculty Clinical Education
    ProSomnus Sleep Technologies
    ROCHESTER HILLS, Michigan, United States

Disclosure(s):
Edward Sall, MD, DDS, MBA: No relevant relationships to disclose.
Mark T. Murphy, DDS: No relevant relationships to disclose.


Introduction: This investigation analyzed adverse event reports (AERs) from the FDA MAUDE database for Continuous Positive Airway Pressure (CPAP), Hypoglossal Nerve Stimulation (HNS), and Oral Appliance Therapy (OAT) devices.

Methods: The FDA MAUDE database was accessed on September 29, 2022. Publicly available industry reports were used to estimate prevalence of AERs.

Results: From Jan. 1, 2022, to Sept. 2022, AERs for CPAP, HNS, and OAT were 72,251, 11,867, and 30, respectively. From Jan. 2017 to Sept. 2022, the annual count of AERs for CPAP and HNS increased 245% and 252%, respectively; the annual count of AERs for OAT decreased by 1.3%.

Device Problems: For CPAP, “Degradation” comprised 96.6% of the AERs. For HNS, “Event Without Problem” and “Device Sensing” comprised 78.6% and 11.0% of AERs, respectively. For OAT, “Event without Identification” and “Breakage” comprised 40.0% and 9.8% of AERs, respectively.

Patient Problems: For CPAP, 7 problems comprise >80% of reports: No Clinical Signs/Conditions, 57.3%; Dyspnea, 5.4%; Headache, 5.3%; Sore Throat, 4.3%; Respiratory Tract Infection, 4.1%; Cough, 3.5%; Unspecified Respiratory, 3.0%.

For HNS, 9 problems comprise >80% of reports: Unspecified Infection, 19%; Pain, 15.2%; No Clinical Conditions, 9.2%; Bacteria Infection, 8.7%; Perforation of Vessels, 7.1%; Erosion, 7.1%; Wound Dehiscence, 4.9%; Swelling/Edema, 4.8%; Hematoma, 4.4%.

For OAT, 7 problems comprise >80% of reports: Hypersensitivity/Allergic Reaction, 23.5%; Reaction, 19.0%; No Known Impact, 15.9%; Swelling, 8.7%; Pain, 6.2%; Discomfort, 4.5%; Erythema, 3.8%; Rash, 3.5%.

Conclusions: This analysis suggests that healthcare providers may wish to consider differences in the frequency and severity of adverse events when prescribing treatment for patients with OSA. Dental side effects, a common reason for limiting the use of OAT devices, are not in the top 80% of the most frequently reported adverse event types. This investigation has limitations. MAUDE relies on reports from manufacturers. HNS is a Class III device whereas CPAP and OAT are Class II, which may result in different approaches to reporting.