Inspire, from the sleep physician’s side
Upper airway stimulation is an implanted device that moves the tongue forward with each breath to keep the airway open. Whether you qualify depends on two different sets of numbers, and the one your insurer uses may not be the one on the FDA label.
What it is
Upper airway stimulation is an implanted device that senses your breathing and delivers a mild impulse to the hypoglossal nerve, moving the tongue forward with each breath to keep the airway open. It is switched on at night with a handheld remote. The current generation is Inspire V, model 3150, whose pulse generator was approved by the FDA in August 2024.
This is the sleep physician’s side of Inspire: who qualifies, what the evaluation involves, and what happens afterwards. The implant itself is done by an ear, nose and throat surgeon.
The two sets of numbers, which are not the same
This is where most pages mislead, usually by quoting whichever limit is more generous. There are two separate thresholds and you need both.
| Criterion | FDA labelling, 2023 | Medicare coverage, LCD L38310 |
|---|---|---|
| Breathing events per hour | 15 to 100 | 15 to 65 |
| Body mass index | Warning limit 40 | Under 35 |
| Age | 22 and over | 22 and over |
| Sleep endoscopy | Used in trial selection | Required, without complete concentric collapse |
In June 2023 the FDA expanded the labelling: the upper limit on breathing events rose from 65 to 100, and the body mass index warning limit rose from 32 to 40. Medicare did not follow. If you are on Medicare, the numbers that decide whether this is covered are a body mass index under 35 and between 15 and 65 events an hour, whatever the FDA label permits.
Medicare’s coverage determination also requires a sleep study within the previous 24 months, predominantly obstructive rather than central events, a documented failure of or intolerance to CPAP, an absence of complete concentric collapse at the soft palate on drug-induced sleep endoscopy, and no other anatomy that would compromise the device.
Drug-induced sleep endoscopy
Before implantation you need a short procedure under sedation in which the airway is examined while you are asleep. Its purpose is to see the pattern of collapse. If the soft palate collapses in a complete circle, the device is unlikely to work and that finding excludes you under Medicare’s rules.
What the evidence shows, stated honestly
The pivotal STAR trial followed 126 patients. At twelve months the median number of breathing events per hour fell from 29.3 to 9.0, a 68 per cent reduction, and 66 per cent of participants met the responder definition of at least a halving of events to below 20 an hour. Serious procedure-related adverse events occurred in under 2 per cent.
Two things about that, because they matter. The median result was 9.0 events an hour, not zero: this is control, not cure, and no honest page should say otherwise. And the twelve-month analysis came from an uncontrolled cohort with a randomised withdrawal substudy, rather than a fully randomised comparison against a sham implant.
The alternative device
Inspire is no longer the only implanted option. The Nyxoah Genio system received FDA approval in August 2025 for adults 22 and over with between 15 and 65 breathing events an hour who have failed, cannot tolerate, or are ineligible for lifestyle change, positive airway pressure, oral appliances and drug therapy. It stimulates both sides of the nerve and has no implanted battery, using an external activation chip worn on an adhesive patch.
Cost
Prior authorisation is the rule rather than the exception, and the packet typically needs a recent sleep study, download data showing CPAP failure or intolerance, your body mass index, the sleep endoscopy report, and a shared decision-making note.
Wondering whether you would qualify?
That question is answered with your sleep study, your body mass index and your insurance, in that order. It is a consultation, not a form.
Call (614) 898-9340Sources
- FDA premarket approval P130008/S098, Inspire V pulse generator, August 2024. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P130008S098
- Inspire Medical Systems, FDA approval for AHI indication expansion and increased BMI labelling, June 2023. https://www.globenewswire.com/news-release/2023/06/09/2685490/0/en/Inspire-Medical-Systems-Inc-Announces-FDA-Approval-for-Apnea-Hypopnea-Index-Indication-Expansion-and-Increased-Body-Mass-Index-Labeling.html
- CMS local coverage determination L38310, hypoglossal nerve stimulation for OSA. https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38310
- Strollo PJ et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 2014;370:139–149. https://www.nejm.org/doi/full/10.1056/NEJMoa1308659
- Nyxoah receives FDA approval for the Genio system, August 2025. https://aasm.org/nyxoah-receives-fda-approval-for-genio-system/