Summary

CARE oral appliaces are custom, removable oromandibular devices intended for daily use to gradually reposition the hard palate and soft tissues in the mouth and nasal passages. The DNA can include upper, lower, or both upper and lower trays to be worn both day and night to provide airway expansion, however only the mRNA and mmRNA devices provide maxillary advancement at night by connecting the upper and lower pieces using a flange or hinge, respectively. Use of the DNA allows for antero-posterior, transverse, and vertical adjustment to increase the maxilla and mandibular witdh. These adjustments can be made by the patient using screws, or by a trained practitioner. Review of the 510(k) documents demonstrates the devices are approved for snoring and mild OSA, or moderate and severe OSA with the use of myofunctional therapy and/or positive airway pressure (PAP) added as needed. The company announced FDA approval “to reduce snoring and treat moderate to severe OSA in children aged 6 to 17” [1], however the 510(k) has not yet been made publically available at the time of this review. 1)

Claimed Capabilities/Measurements

The CARE (Complete Airway Repositioning and/or Expansion) line of oral appliances are indicated to treat all severities of obstructive sleep apnea (OSA) in adults and children by expanding the nasal passages using jaw expansion and mid-facial respositioning, in addition to nighttime maxillary advancement. These are marketed as the first oral medical devices with FDA indications to treat OSA in children and first to treat severe OSA in adults, however for the indication of moderate and severe OSA myofunctional therapy and/or positive airway pressure (PAP) are to be added as needed. The products use include the DNA (Daytime-Nighttime Appliance) for airway expansion, and the mRNA and mmRNA devices (mandibular Repositioning Nighttime Appliances) at night to add maxillary advancement.

Mechanism

Devices use standard orthodontics acrylics and wires.

Sensors

None

Technical Considerations

These oral appliances are fitted and adjusted by trained dentists, with the company requiring providers enroll and complete training specific to Vivos devices. The Vivos Provider Network lists certified providers. Vivos does not allow individual labs to create the devices; Vivos-approved contract labs manufacture all devices.

Publications

Citation: Dao N, Cozean C, Chernyshev O, Kushida C, Greenburg J, Alexander JS. Retrospective Analysis of Real-World Data for the Treatment of Obstructive Sleep Apnea with Slow Maxillary Expansion Using a Unique Expansion Dental Appliance (DNA). Pathophysiology. 2023 May 9;30(2):199-208. doi: 10.3390/pathophysiology30020017. PMID: 37218915; PMCID: PMC10204354.

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Study Summary: In addition to mandibular advancement devices, dental expansion appliances are an important clinical approach for achieving an increased intra-oral space that promotes airflow and lessens the frequency or severity of apneic events in patients diagnosed with obstructive sleep apnea (OSA). It has been thought that dental expansion in adults must be preceded by oral surgery; however, in this paper, we examine the results of a new technique for slow maxillary expansion without any surgical procedures. The palatal expansion device, DNA (Daytime-Nighttime Appliance), was reviewed in this retrospective study, particularly regarding its effects on measurements of transpalatal width, airway volume, and apnea-hypopnea indices (AHI) as well as its common modalities and complications. The DNA effectively reduced AHI by 46% (p = 0.00001) and significantly increased both airway volume and transpalatal width (p < 0.00001). After DNA treatment, 80% of patients showed some improvement in AHI scores with 28% of patients having their OSA symptoms completely resolved.

Citation: Katz D, DeMaria S, Heckman S, Lin F, Kushida C. Use of the Complete Airway Repositioning and Expansion (CARE) approach in 220 patients with Obstructive Sleep Apnea (OSA): A retrospective cohort study. Sleep Med. 2022 Nov;99:18-22. doi: 10.1016/j.sleep.2022.07.005. Epub 2022 Jul 11. PMID: 35921719.

DOI:

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Study Summary: Obstructive sleep apnea (OSA) is a prevalent disease with significant health repercussions. While many effective OSA treatment modalities exist, Complete Airway Repositioning and Expansion (CARE) represents an emerging approach that leverages gradual airway expansion, with or without mandibular advancement. The authors conducted a retrospective study of patients who underwent CARE with a dental provider and examined how their sleep study data changed, with a focus on apnea hypopnea index (AHI). A retrospective database of 220 adult patients was examined. Demographic data and radiographic and sleep study data were compared in patients before and following at least 6 months of treatment with one of two possible dental devices. The median age of patients in this cohort was 50 years, and evenly split by gender. The median decrease in AHI was 49.0%, with a median pre-treatment AHI of 17.3 and median post-treatment AHI of 9.6 (p<0.001). Most participants (63.6%) demonstrated an improvement in their OSA severity class. Fifty-seven (25.9%) participants had complete resolution of their OSA. Post-treatment, 151 (68.6%) of patients had OSA severities of none or mild. Thirty-four (15.5%) of patients had in increase in AHI and 13 (6.0%) of these patients demonstrated an increase in OSA classification.

Related Technologies

The following reviews should be published soon: Slow Wave DS8, Hushd Pro Avera, Silent Nite 3D, Prosomnus EVO, SomnoGuard (AP Pro, SPX, AP 2, 3), EMA 3D.