What’s going on
This page is for adults with a sleep apnea diagnosis who are weighing their options. If you haven’t been tested, start with a physician. Only a physician can diagnose sleep apnea.
There are three common devices. CPAP Strong pushes air through a mask. A custom oral appliance Some holds your lower jaw forward. Inspire Strong is an implant that moves your tongue forward as you breathe in during sleep.
They aren’t three equal choices. They come in an order, and the order depends on your test results, your airway and how CPAP has gone for you.
How they compare
| CPAP | Custom oral appliance | Inspire implant | |
|---|---|---|---|
| What it is | Mask and air pump | Custom mouthpiece that holds the jaw forward | Implanted nerve stimulator with a remote |
| Who it’s for | Most adults with sleep apnea | Those who can’t use CPAP or prefer another option | Selected adults with moderate to severe apnea who failed or can’t tolerate CPAP |
| Who prescribes | Sleep physician | Sleep physician; a dentist makes it | Sleep physician and ENT surgeon |
| Surgery | No | No | Yes, to place the implant |
| Follow-up | Machine data, plus visits | Sleep test with the appliance in | Setting adjustments, checked with sleep testing |
CPAP: the usual first step
The AASM strongly recommends CPAP for adults with obstructive sleep apnea and excessive sleepiness. It lowers breathing pauses more than the other options, when you wear it.
Most CPAP trouble has a fix: a different mask, a humidifier, the ramp setting or a pressure change. Work through those with your care team before you move on. See CPAP alternatives for the troubleshooting steps.
Custom oral appliance: the main alternative
The AASM and AADSM guideline recommends a custom, adjustable appliance, rather than no treatment, for adults who can’t tolerate CPAP or prefer another treatment. A sleep physician prescribes it. A qualified dentist makes and adjusts it.
It lowers breathing pauses less than CPAP, but many people wear it more. The guideline suggests a follow-up sleep test to confirm it’s working. See oral appliance vs CPAP for the full comparison.
A store-bought snoring mouthpiece is not a substitute. None is cleared by the FDA for sleep apnea.
Inspire: who the FDA approved it for
Inspire is an FDA-approved implant. The FDA first approved it in 2014 under premarket approval P130008. The indications were widened in June 2023. In August 2024, the FDA approved the newer Inspire V system, with an updated stimulator and remote.
Per the FDA’s 2023 summary, Inspire is for adults 22 and older who:
- Have moderate to severe obstructive sleep apnea, with an AHI of 15 to 100
- Have been confirmed to fail CPAP or can’t tolerate it
- Don’t have complete concentric collapse at the soft palate (a ring-shaped collapse of the airway behind the roof of the mouth)
The FDA defines CPAP failure as an AHI still above 15 on CPAP. Intolerance means you can’t use it more than 4 hours a night, 5 nights a week, or you’re unwilling to (for example, you returned the machine). It’s also approved for some people aged 18 to 21, and for some teens 13 to 18 with Down syndrome, under stricter criteria.
It isn’t for you if (FDA contraindications):
- Central and mixed apneas make up more than 25% of your AHI
- Your airway anatomy would block it from working, such as that complete concentric collapse
- A condition or surgery has affected nerve control of your upper airway
- You can’t operate the remote, alone or with help
- You’re pregnant or plan to be
- You have another implant that could interact, or need MRI scans outside the device’s MRI labeling
About weight: the FDA summary notes that safety and effectiveness data now cover a body mass index up to 40, up from 32. That’s a label warning, not a strict cutoff, and insurers may set lower limits.
How candidacy is checked
Before an implant, you’ll typically have a recent sleep study and a drug-induced sleep endoscopy (DISE). DISE is a short procedure where a surgeon looks at your airway with a thin scope while you’re sedated. It shows how and where your airway collapses.
Results and risks
In the main five-year study (STAR), 71 people had a sleep study at five years. Of those, 75% met the study’s definition of success. That was an AHI under 20 with at least a 50% drop. Counting dropouts, the rate was 63%.
Those patients had a body mass index under 32 and a favorable DISE. Serious device-related problems, all needing lead or device adjustments, occurred in 6%. The study was industry-supported.
Medicare and cost
We didn’t find a cost figure from a government or medical society source, so we don’t give one here. Ask the surgeon’s office and your insurer for an estimate before you schedule.
Medicare coverage is set by regional contractors. One local coverage determination (L38528, revised March 2026) covers Inspire only when all of these are met:
- Age 22 or older, with a body mass index under 35
- A lab sleep study (polysomnography) within 24 months of the first consultation
- An AHI of 15 to 65, with central and mixed apneas under 25%
- Documented CPAP failure or intolerance, including shared decision-making
- No complete concentric collapse on DISE, and no other blocking anatomy, such as very large tonsils
Notice the AHI and BMI limits are tighter than the FDA label. Private plans set their own rules, so ask about prior approval.
What a dentist or doctor can do
Your sleep physician reviews your test and your CPAP history and decides what to try next. For Inspire, they refer you to an ENT surgeon who does the airway exam and the implant. After surgery, the physician adjusts the stimulation settings. In the registry data the FDA reviewed, patients then had yearly visits with a lab or home sleep test to check results and adjust settings.
A dentist trained in dental sleep medicine makes custom appliances on a physician’s prescription. They also watch for changes in your teeth and bite.
What not to do
- Don’t skip CPAP troubleshooting. Inspire requires a documented CPAP failure or intolerance.
- Don’t assume a BMI or AHI number rules you in or out. The FDA label and your insurer’s rules may differ.
- Don’t stop CPAP before you have a plan agreed with your physician.
Reviewed by Ryan Smith, DDS on September 27, 2026. It explains snoring and sleep in general and isn’t a diagnosis; only a physician can diagnose sleep apnea. Medical disclaimer. Spot an error? Tell us.
Sources
- Inspire Upper Airway Stimulation, P130008/S090 (FDA, 2023)
- Summary of Safety and Effectiveness Data, Inspire UAS P130008/S090 (FDA)
- FDA approves next-generation Inspire V therapy system (AASM, 2024)
- Woodson BT, et al. Upper airway stimulation for OSA: 5-year outcomes (Otolaryngol Head Neck Surg, 2018)
- LCD L38528: Hypoglossal nerve stimulation for the treatment of OSA (CMS Medicare Coverage Database)
- Ramar K, et al. Clinical practice guideline for oral appliance therapy for OSA and snoring (AASM/AADSM, J Clin Sleep Med, 2015)
Evidence badges link to the study behind each rating. How we rate evidence.