Multiple FDA-cleared alternatives to traditional CPAP machines are now offering sleep apnea patients relief without the cumbersome masks that have plagued sufferers for decades.

Story Overview

• Four breakthrough sleep apnea devices received FDA clearance in late 2025, providing CPAP alternatives
• New oral appliances now FDA-approved for severe sleep apnea, previously requiring CPAP or surgery
• Adaptive pressure technology addresses comfort issues that caused poor CPAP adherence rates
• 61 million Americans with sleep apnea gain access to personalized, user-friendly treatment options

Revolutionary Devices Break CPAP Monopoly

SleepRes Inc. received FDA clearance on December 17, 2025, for its Kricket PAP device featuring Kairos Positive Airway Pressure technology. Unlike traditional CPAP machines that deliver constant pressure, this adaptive system adjusts pressure throughout each breathing cycle. The device targets patients weighing over 66 pounds with obstructive sleep apnea, addressing the comfort concerns that have historically plagued CPAP therapy adherence.

Vivos Therapeutics achieved a significant milestone in 2025 with FDA clearance for its CARE oral appliances, marking the first oral device approved for moderate-to-severe sleep apnea in adults. The DNA, mRNA, and mmRNA models offer severe OSA patients an alternative to CPAP machines, neurostimulation implants, or invasive surgical procedures. CEO Kirk Huntsman emphasized this breakthrough provides “a far more desirable option that is very affordable and doesn’t require surgery.”

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Market Competition Challenges Medical Device Giants

Good Sleep Co secured FDA clearance on October 27, 2025, for the Hushd Pro Z-Link oral appliance, a 3D-printed mandibular advancement device targeting mild-to-moderate OSA and snoring. This approval expands patient options beyond the traditional CPAP-dominated market, creating direct competition for established medical device manufacturers who have controlled sleep apnea treatment protocols for decades.

Resmed responded to increasing competition by obtaining FDA clearance on December 8, 2025, for Smart Comfort, an AI-enabled system that personalizes CPAP settings. The technology uses artificial intelligence to recommend comfort settings for patients using AirSense 11 devices, attempting to address adherence problems through data-driven personalization rather than hardware alternatives.

Patient Liberation From Government-Healthcare Complex

These FDA approvals represent a victory for patient choice against a medical establishment that has long forced Americans into one-size-fits-all CPAP treatments. For decades, the healthcare bureaucracy pushed expensive CPAP machines despite poor adherence rates, leaving 61 million Americans with limited options. The new devices prioritize real-world usability over institutional preferences, giving patients control over their treatment decisions.

David White, Chief Medical Officer of SleepRes and Harvard Medical School professor, stated the Kricket device “prioritizes comfort, the patient’s ability to adapt, and real-world use.” This patient-centered approach contrasts sharply with the previous system where medical providers prescribed CPAP machines regardless of individual tolerance levels or lifestyle compatibility.

Healthcare Innovation Overcomes Regulatory Barriers

The simultaneous FDA clearances signal a broader shift in sleep medicine toward diversified treatment options. Commercial launches are planned throughout 2026, with Resmed’s Smart Comfort entering limited beta testing for myAir app users early in the year. SleepRes expects to launch the Kricket PAP commercially in the first half of 2026, while Vivos’ CARE appliances are immediately available to qualified patients.

These developments demonstrate how private sector innovation can overcome regulatory obstacles when companies prioritize patient outcomes over bureaucratic compliance. The new devices offer hope for the estimated 77 million Americans projected to have sleep apnea by 2050, ensuring treatment options will expand rather than remain trapped in outdated protocols favored by the medical establishment.

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Sources:

SleepRes wins FDA clearance for new sleep apnea device
FDA clears Vivos oral appliances severe sleep apnea
FDA clears Hushd Pro Z-Link oral appliance for sleep apnea and snoring
Resmed receives FDA clearance for personalized therapy comfort settings