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Sleep Medicine

(202) FDA Adverse Event Reports Vary Based on OAT Device Design

Monday, October 2, 2023
2:45 PM – 3:45 PM East Coast USA Time
Has Audio
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 whether OAT device design impacts the frequency of adverse event reports (AERs).

Methods: The publicly available FDA MAUDE database was accessed on September 29, 2022. Investigators used data from public sources (e.g., Frost & Sullivan) to estimate prevalence.

Results: Since 2017, 352 AERs have been reported. The most common AERs are Reactions (allergic, swelling, rash) and Pain/Discomfort. Only 2.5% of AERs pertain to dental side effects (tooth movement, bite changes).

Materials: 98.5% of AERs involved OATs made from lab materials. 1.5% involved OATs made from engineered materials. OATs with lab formed materials were 22.6x more likely to have an AER than those with engineered materials.

Structural Composition: AERs related to structural composition were as follows: metal components: 55.6%; elastomeric/nylon components: 42.4%; monolithic structures: 2.0%. Compared with monolithic OATs, OATs with metal components or elastomeric/nylon components were 18.2x and 13.9x more likely to have an AER, respectively.

Titration Mechanism: OATs with anterior clasp mechanisms, push mechanisms, pull mechanisms, 70° dorsal posts, and 90° twin posts accounted for 45.0%, 42.7%, 6.1%, 5.6%, and 0.6% of AERs, respectively. Compared with 90° twin post mechanisms, OATs with push or pull mechanisms were 154x and 146x more likely to have an AER, respectively.

Liners: Lab formed OATs with liners, lab formed liner-less OATs, and precision engineered liner-less OAT devices accounted for 77.3%, 21.2%, and 1.5% of AERs, respectively. OATs with liners were 35.5x more likely to have an AER than precision engineered liner-less OATs.

Conclusions: AER frequency varies based on OAT device design. OAT devices that use precision engineered materials, monolithic structures, 90° twin posts and precision engineered liner-less designs are associated with low frequencies of AERs.

The results of this investigation suggest that medical guidelines and insurance coding should empower therapy providers with the flexibility to prescribe devices that are associated with fewer AERs.