aura6000 hypoglossal nerve stimulation by LivaNova: status and timeline

Milestones

Next · MRI-compatible next-generation aura6000

FDA approves clinical studyJun 2021Complete.
OSPREY randomized controlled trial completes2026Complete.
FDA PMA approval for moderate-to-severe OSA19 Mar 2026Complete.
MRI-compatible next-generation aura6000Target Q1 2027Current milestone.

Most important updates

LivaNova receives FDA PMA approval for aura6000 hypoglossal nerve stimulation for moderate-to-severe sleep apnea19 Mar 2026

Upcoming

Q1 2027MRI-compatible next-generation aura6000 (next)

Current obstacles

Patient selection criteriaThe device is approved for AHI 15–65 and excludes patients with complete concentric collapse; determining candidacy requires sleep medicine expertise.
Surgical implantationImplantation requires a procedure under general anesthesia; patient acceptance and surgical training limits uptake.

Physics limits

Anatomical exclusionsPatients with complete concentric collapse of the airway at the palate level are excluded, limiting the addressable market within OSA patients.
Stimulation power and battery lifeThe implanted device must be recharged periodically; frequency depends on stimulation intensity and patient compliance.

How it works

3 parts

Nerve stimulation

Electrical pulses to the hypoglossal nerve

An electrode implanted on the hypoglossal nerve delivers synchronized pulses to strengthen the tongue and keep the airway open during sleep.

Selective targeting

Proximal stimulation

Proximal stimulation avoids complete concentric collapse contraindication, broadening candidacy vs. competitors.

Patient control

Wearable remote activation

Patients activate the device at bedtime with a wearable remote, and it stimulates throughout the night.

Spec sheet

Spec	aura6000 hypoglossal nerve stimulation
OSPREY responder rate (≥50% AHI)	65%^R (reported)
OSPREY on-therapy AHI at 12 months	<20^R (reported)
Approved indication: AHI range	15–65^R (reported)

^R reported by the company

Update log

1 update

Thu 19 Mar

Major: LivaNova receives FDA PMA approval for aura6000 hypoglossal nerve stimulation for moderate-to-severe sleep apneaPressRegulatory

About LivaNova

The team behind aura6000 hypoglossal nerve stimulation

LivaNova

VNS therapy epilepsy depression, cardiac devices

Publicly traded neuromodulation and cardiac surgery devices. VNS Therapy treats drug-resistant epilepsy and treatment-resistant depression by stimulating the vagus nerve.

VNS Therapy leads epilepsy with 80% seizure reduction (CORE-VNS). Pursuing Medicare coverage for treatment-resistant depression.
RECOVER trial showed 52% benefit in depression at 24 months. Revenue $1.43B (TTM Mar 2026) with double-digit growth.
Established player in neuromodulation with 2,900 employees and expanding reimbursement for end-of-service procedures.

livanova.com (opens livanova.com)Company profile →

Founded: 201511 yrs
Headquarters: United Kingdom
Status: Public
Listed: LIVN (opens google.com)NASDAQ
Valuation: public
Staff: ~2,955Dec 2025
Works in: NeurotechStimulation therapies
Coverage: 2 programs · 5 updateslatest 19 Mar 2026checked 10 Oct
Partners: Medicare (CMS) (opens cms.gov)
People: Vladimir Makatsaria (opens investor.livanova.com)Chief Executive OfficerWilliam Kozy (opens livanova.com)Chair of Board of Directors

Spec

aura6000 hypoglossal nerve stimulation

OSPREY responder rate (≥50% AHI)

65%^R (reported)

OSPREY on-therapy AHI at 12 months

<20^R (reported)

Approved indication: AHI range

15–65^R (reported)