Implantable Sleep Apnea Devices: The FDA-Approved Options Compared

As of October 2026, the FDA has approved three implants for obstructive sleep apnea (OSA): Inspire, Genio and aura6000. All three stimulate the nerve that moves the tongue so the airway stays open during sleep. A fourth implant, remedē, treats central sleep apnea, which is a different problem. These devices are for some adults who could not use CPAP, and each one has its own rules about who qualifies.

What a sleep apnea implant does

In OSA, the tongue and throat relax during sleep and block the airway. Breathing stops or gets shallow many times an hour. CPAP fixes this by blowing air through a mask. An implant takes a different route: it sends a mild signal to the hypoglossal nerve, which moves the tongue forward and keeps the airway open.

A surgeon places the implant, and you turn it on at night. If you want to know how the tongue and nerve work and what stimulation feels like, read our guide to how hypoglossal nerve stimulation works.

The three FDA-approved implants for obstructive sleep apnea

• Inspire — FDA-approved in 2014, the first of the three. It stimulates the nerve on one side and is timed with your breathing by a sensor lead. It has an implanted battery, and you turn it on with a small remote. It is approved for an AHI of 15 to 100, a BMI up to 40, and adults 18 and older, plus some teens 13 and older with Down syndrome.^[6] In its main study, the median AHI fell from about 30 to about 9 events an hour after 12 months.^[1] Our Inspire therapy guide covers the surgery and recovery.
• Genio — FDA-approved in August 2025. It stimulates the nerve on both sides. The implant has no battery; a small part worn under the chin at night powers it and is charged each day. It is approved for an AHI of 15 to 65 in adults 22 and older, and the approval study used a BMI limit of 32.^[6] In that study, about 64% of people met the study's goal for fewer breathing pauses at 12 months.^[2]
• aura6000 — FDA-approved in March 2026. It stimulates the nerve closer to where the nerve starts, using a generator implanted in the chest. It is approved for an AHI of 15 to 65 in adults who could not use or did not get relief from treatments such as CPAP, and the approval study used a BMI limit of 35.^[6] In a randomized trial, about 58% of treated people met the study goal at 7 months, compared with about 14% of people whose device was not yet turned on.^[3]

These studies used different people and different goals, so their numbers cannot be compared head to head. Doctors are still learning which device suits which person.

An implant for central sleep apnea: remedē

Central sleep apnea is different from OSA. The airway is open, but the brain does not send a steady signal to breathe. It is more common in people with heart failure, after a stroke, or with opioid use.

The remedē system was FDA-approved in October 2017 for adults with moderate to severe central sleep apnea.^[6] A thin lead placed in a vein near the phrenic nerve signals the diaphragm, the main breathing muscle, to breathe. In its main trial, about half of treated people had their AHI cut by half or more at 6 months, compared with about 1 in 10 people whose device was off.^[4] It is not a treatment for obstructive sleep apnea.

Who may qualify for an implant

Rules differ by device, but most people who are considered have:

• Moderate to severe sleep apnea — an apnea-hypopnea index (AHI) of 15 or more on a recent sleep study. Learn what the number means in sleep study results and AHI explained.
• Tried CPAP first — they could not use it or did not get relief from it.
• Mostly obstructive events — the hypoglossal implants are for OSA, not central apnea.
• A BMI within the device's limit — the limit differs for each implant, and many insurance plans set their own.

Sleep medicine guidelines recommend that doctors talk with adults who have OSA, a BMI under 40 and trouble with CPAP about seeing a sleep surgeon.^[5] For non-surgical choices too, see CPAP alternatives.

The airway exam: drug-induced sleep endoscopy (DISE)

DISE is a short test done by a surgeon. You get medicine to fall asleep, and a thin camera passes through your nose to watch how your airway closes.

• Inspire and Genio — DISE is required. A pattern called complete concentric collapse, where the airway closes in a ring at the soft palate, rules these devices out.^[6]
• aura6000 — its label does not require DISE and has no warning about complete concentric collapse.^[6] Your surgeon may still suggest an airway exam.

Questions to ask before choosing an implant

• Which devices fit my sleep study? — your AHI, BMI and type of apnea decide which ones are possible.
• Do I need DISE? — and what happens if it shows complete concentric collapse.
• What is the surgery like? — how many cuts, how long recovery takes, and the risks.
• How is it powered and charged? — some run on an implanted battery; others use a part you wear or charge.
• Can I have an MRI later? — MRI rules differ by device.
• Will my insurance cover it? — plans often have their own rules.

For a look at other new options, including the first medicine for sleep apnea, see new sleep apnea treatments.

When to see a sleep specialist

• CPAP is not working for you — you cannot sleep with the mask, or you still feel tired.
• Your sleep study is old — most implants need a recent study to check that you qualify.
• You have heart failure and pauses in breathing — you may need testing for central sleep apnea.
• You have an implant and symptoms return — snoring, gasping or sleepiness can mean the settings need a check.

Sleep apnea care in Cedar Park

Dr. Minal Patel is board-certified in pediatrics and sleep medicine. Our practice offers in-lab and home sleep studies, CPAP and BiPAP therapy, and Inspire evaluation. We do not perform surgery. We are accepting new patients. Office hours are Monday through Friday, 8:30 to 5:00. We accept Medicaid and CHIP for sleep patients. We do not take walk-ins.