Devices

FDA-approved hypoglossal nerve stimulator for obstructive sleep apnea, newest version Inspire V approved August 2024. Thinly sourced from the FDA overview and supplement record; many cells stay Unreported.

Catalog specification sheet - Peripheral nerve

Inspire upper airway stimulation

Primary source →

Record ID
BTSD-FDA-0009
Reviewed
2026-10-08
Interface
pni
Evidence stage
human

Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.

Inspire upper airway stimulation

Inspire is an implanted hypoglossal nerve stimulator with a sensing lead that tracks breathing. This sheet uses the FDA overview for the June 2023 indication expansion and the supplement record for the Inspire V IPG (Model 3150, decision August 1, 2024). Lead and electrode specifications are not in those sources and stay Unreported.

Identity

FieldValue and source scope
DeviceInspire Upper Airway Stimulation system: IPG, stimulation lead, sensing lead, physician programmer and patient remote; Inspire V Model 3150 IPG is the newest version [1][2]
ManufacturerInspire Medical Systems, Inc. [1][2]
Interface classImplanted nerve stimulator with a breathing-sensing lead and a hypoglossal stimulation lead [1][2]
OriginCommercial FDA-approved device, PMA P130008 [1][2]
First demonstratedUnreported
First human implantUnreported
Species studiedUnreported
Regulatory statusPMA P130008. S090 approved June 8, 2023 (indication expansion). S098 decision August 1, 2024 approved the Inspire V Model 3150 IPG as the new version of the Model 3028 [1][2][3]
FunctionIPG detects the patient’s breathing pattern and stimulates nerves to maintain an open airway during sleep; used for obstructive sleep apnea [1]
Target tissueHypoglossal nerve (generic name: stimulator, hypoglossal nerve, implanted, apnea) [2]

Geometry and architecture

FieldValue and source scope
Interface typeUnreported
Array layoutUnreported
Electrode countUnreported
PitchUnreported
Electrode lengthsUnreported
Shank width and thicknessUnreported
Tip and exposed site geometryUnreported
Contact coatingUnreported
InsulationUnreported
Insertion methodUnreported
Anchoring and fixationUnreported

Electrode and channel physics

FieldValue and source scope
Exposed site areaUnreported
Electrode materialUnreported
Impedance (with measurement frequency)Unreported
Noise floor or SNRUnreported
Recording modalityUnreported
Sampling rateUnreported
Stimulation capabilityUnreported
Charge injection limitUnreported
Reference and groundUnreported

Tissue interface and bioresponse

FieldValue and source scope
Target tissueUnreported
Insertion trauma and BBB disruptionUnreported
Vascular disruption riskUnreported
Micromotion sensitivityUnreported
Gliosis and encapsulationUnreported
Neuron loss near sitesUnreported
Foreign-body response mitigationUnreported
Typical failure modesUnreported

System architecture

FieldValue and source scope
Onboard electronicsIPG with breathing sensing; Inspire V adds a Bluetooth patient remote and physician programmer per the company release [1][3]
Data pathPhysician programmer sets stimulation; patient remote turns therapy on before sleep and off on waking [1]
Telemetry bandwidthUnreported
Sampling rateUnreported
PowerUnreported
Thermal managementUnreported
Packaging and hermeticityUnreported
MRI compatibilityUnreported
Surgical complexityUnreported
Output connectorsUnreported

Performance envelope

FieldValue and source scope
Acute yieldUnreported
Chronic yieldUnreported
Stability over timeUnreported
LongevityUnreported
Revision and explant experienceUnreported
Adverse eventsUnreported
Notable demonstrationsUnreported

Clinical and preclinical evidence

FieldValue and source scope
Human subjectsUnreported
Preclinical cohortUnreported
Follow-up durationUnreported
IndicationsModerate to severe obstructive sleep apnea (AHI 15 to 100), age 22 and older, unable to use or tolerate PAP or BiPAP, and without complete concentric collapse of the soft palate; S090 raised the AHI limit from 65 to 100 and the BMI limit from 32 to 40 [1]
Trials and registriesUnreported
Primary outcomesUnreported
Key limitationsThe FDA overview and supplement record carry no lead geometry, electrode count, battery or trial outcome data. The SSED was not read. The Inspire V soft launch was targeted for late 2024 with full launch in 2025 per the company [1][2][3]

Engineering tradeoffs

FieldValue and source scope
StrengthsUnreported
LimitationsUnreported
Scaling constraintsUnreported

Version boundary

Inspire V Model 3150 is the new version of the Model 3028 IPG. The FDA overview describes the system at the S090 approval, before Inspire V.

References

  1. FDA overview, Inspire Upper Airway Stimulation, P130008/S090.
  2. FDA PMA P130008/S098 record.
  3. Inspire Medical Systems announcement, August 2, 2024.