Inspire vs Nyxoah Genio: two implants compared

Two FDA-approved implants treat obstructive sleep apnea by stimulating the hypoglossal nerve. Inspire uses an implanted pulse generator with a battery in the chest. Nyxoah’s Genio System 2.1, approved 8 August 2025, places a battery-free stimulator under the chin and powers it each night from an external chip on an adhesive patch. The labels are not interchangeable. Genio’s indication also requires that lifestyle change, PAP, an oral appliance, and pharmacotherapy such as tirzepatide have already failed, been intolerable, or been ineligible.

How do the two devices actually differ?

Inspire’s system, in the form described in Medicare LCDs and in STAR, has an implanted generator, a stimulation lead on the hypoglossal nerve, and (in earlier models) a sensing lead in the chest wall. The current IPG is Inspire V, Model 3150, approved 1 August 2024 under PMA P130008/S098 as the successor to Model 3028. The patient turns therapy on and off with a remote. Stimulation is timed to breathing.

Genio’s PMA P240024 Summary of Safety and Effectiveness Data describes an Implantable Stimulator (IS) Model 2954 sutured over the genioglossus under the chin, with paddle electrodes facing both left and right hypoglossal branches. The implant has no battery and no software. An Activation Chip snaps onto a disposable adhesive patch under the chin and sends energy wirelessly. A charging unit recharges the chip by day. A smartphone app can pause therapy and change amplitude inside a physician-set range. Default delay from connecting the chip to the start of stimulation is 30 minutes (configurable 5 to 60). The SSED lists the implant as MR Conditional at 1.5 T and 3 T under specified conditions.

Bilateral versus unilateral stimulation is the other hardware difference patients ask about. Genio’s labeled design is bilateral hypoglossal stimulation from a single under-chin implant. Inspire’s STAR implant stimulated a selected branch of one hypoglossal nerve. That is a design contrast. It is not proof that one is “twice as strong.” Trials measured different cohorts with different inclusion rules.

This practice evaluates people for Inspire therapy. Whether Genio is offered here is a separate operational fact and should not be assumed from this comparison. current device availability before a consult is booked around Genio.

Who is on each FDA label?

Inspire’s 8 June 2023 supplement (P130008/S090) expanded the adult indication to moderate to severe OSA with AHI 15 to 100, age 22 and older, after PAP failure or intolerance, and raised the BMI warning to 40. Medicare payment in Ohio still uses AHI 15 to 65 and BMI under 35. Those payer rules are not Genio’s problem or Inspire’s label; they are LCD rules.

Genio System 2.1 is indicated for moderate to severe OSA with AHI greater than or equal to 15 and less than or equal to 65, in adults 22 and older, “who have been confirmed to fail, cannot tolerate or are ineligible to be treated with current standard of care treatments including lifestyle modifications, positive airway pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bi-level positive airway pressure [BiPAP] machines), oral appliances (such as mandibular advancement devices), and pharmacotherapy (such as tirzepatide).” PAP failure on that label is residual AHI greater than 15 despite PAP use. PAP intolerance is inability to use PAP at least 5 nights per week for more than 4 hours, or unwillingness after PAP was started and then stopped by choice.

Read the conjunction. Genio’s indication names lifestyle, PAP, oral appliances, and pharmacotherapy. Tirzepatide is the example the FDA text uses. A person who has only failed CPAP may meet Inspire’s PAP clause and still be short of Genio’s listed standard-of-care list until an oral appliance and a medication conversation are documented, or until the clinician documents ineligibility for those treatments. That is label language, not this office’s preference.

The Genio indications paragraph in the SSED does not print a BMI cutoff. DREAM enrolled people with BMI of 32 or less; that was a trial inclusion criterion, mean BMI 28.50. Do not treat 32, 35, or 40 as Genio’s labeled BMI limit. It is not stated in the indication statement we opened.

What did STAR and DREAM actually measure?

STAR (NCT01161420) implanted 126 people with the Inspire system. Mean age 54.5, 83% men, mean BMI 28.4. Screening AHI had to fall between 20 and 50 at the time of that trial, which is tighter than today’s FDA window. CCC on DISE was an exclusion. At 12 months, median AHI went from 29.3 to 9.0 events per hour (68% reduction). Median ODI went from 25.4 to 7.4 (70%). An AHI responder (at least 50% reduction and AHI under 20) was 66% (83 of 126). ODI response (at least 25% reduction) was 75%. Procedure-related serious adverse events were under 2%. The 12-month analysis was a prospective single-group cohort. A randomized withdrawal in 46 consecutive responders then showed that turning the device off for a week brought events back. STAR was not a fully randomized pivotal trial of implant versus sham implant for the primary 12-month endpoint.

DREAM, the Genio pivotal study under IDE G190068, implanted 115 people at 22 sites. The SSED’s full analysis set for effectiveness was 110 (three Australian implants were excluded from FAS for monitoring/GCP reasons). Co-primary endpoints at 12 months, scored by a core lab on full-night PSG with fixed settings, were AHI4 response (Sher criteria: ≥50% reduction and residual AHI4 < 20) and ODI4 response (≥25% reduction). On the FAS, AHI4 responder rate was 66.4% and ODI4 responder rate was 74.5%. Company press materials have also quoted 63.5% and 71.3%. Those press-release figures disagree with the SSED FAS numbers; this article uses the SSED. DREAM also used DISE to exclude complete concentric collapse. Mean BMI in the safety set was 28.50. Trial BMI ceiling was 32 kg/m².

Those two responder rates look similar if you squint. They are not a head-to-head. Different AHI windows at screening, different BMI rules in the trials, different years, no randomized comparison of Inspire versus Genio. Anyone quoting “they work the same” is flattening two single-arm studies.

What does “no implanted battery” change about a night of sleep?

Inspire’s battery lives in the chest generator. Replacement is a future surgery when the battery is depleted. LCD background text still quotes a 7-to-10-year range for the implantable components of the system it describes; that figure is LCD background, not a promise for Model 3150. Genio’s SSED gives the IS Model 2954 a service life of at least 12 years and the Activation Chip at least 12 months. The chip and the disposable patch are nightly hardware. If the patch does not stick, or the chip is not charged, there is no stimulation that night. Application-site irritation was the most common non-serious event in DREAM (28 of 115, 24.3%).

Neither device removes the need to turn therapy on. STAR’s self-reported daily use was 86% at 12 months. Genio users still place a patch and a chip. People who wanted “nothing on the body” will not get that from Genio. They get nothing implanted that holds a battery, and they still wear something on the chin.

How should a patient in Westerville think about the choice?

Start with the disease and with PAP. Both labels sit after PAP failure or intolerance. CPAP alternatives also include oral appliances, which Genio’s indication names explicitly. Medication for OSA in adults with obesity is now a labeled use of tirzepatide; Genio’s FDA text treats that class as part of standard care you must have failed, not tolerated, or been ineligible for.

Then match AHI to the label that will actually be billed. Inspire’s FDA AHI goes to 100; Genio’s stops at 65. Medicare’s Inspire payment window is 15 to 65 anyway. BMI: Inspire has a warning at 40 and Medicare payment under 35. Genio’s indication is silent on BMI; DREAM did not enroll above 32.

DISE still sits in front of both trial populations. CCC remains a Medicare exclusion for hypoglossal nerve stimulation and was a DREAM exclusion. A concentric palate is not a reason to “try the other brand” without reading that brand’s current U.S. label and the payer policy.

Do not use cash prices quoted by other clinics, device companies, or dental-sleep blogs as this practice’s fee. Implant plus facility plus surgeon is billed in pieces. Prior authorization is expected. For sleep apnea that still needs a diagnosis or a new study, start there. For a comparison visit, call (614) 898-9340. Bring both sleep-study reports if you have them, the CPAP download, and any oral-appliance or medication notes. The office is at 450 Alkyre Run Drive, Suite 230, Westerville, OH 43082.