On August 8, 2025 Nyxoah’s Genio system—a bilateral, leadless hypoglossal nerve stimulator— received FDA approval for treating moderate to severe Obstructive Sleep Apnea (OSA), with an AHI range of 15 to 65.
What is unique about Genio?
Bilateral stimulation (company feels this offers more balanced tongue protrusion)
Leadless, MRI-compatible design
Externally powered and upgradeable, avoiding repeat surgeries for battery swaps or tech upgrades.
This approval allows Nyxoah to move beyond Europe and officially launch Genio in the U.S. market.
The Data to Support: DREAM Study
The approval was based chiefly on results from the DREAM trial, recently published in the Journal of Clinical Sleep Medicine 7/24/25.
Study: Single-arm, multi-institutional study of the implantable Genio device.
Of note, DISE was used to exclude complete concentric collapse (CCC) patients, similar to Inspire. Nyxoah has previously posited that their device may achieve efficacy without requiring upfront DISE stratification.
Primary outcomes (completed in 115 patients):
-AHI Responder Rate (Sher criteria): 63.5%
-ODI Responder Rate: 71.3%
Secondary outcomes (completed in 89 patients):
-Statistically significant improvements in overall AHI/ODI scores
-Statistically significant improvements in subjective QOL scores like ESS, FOSQ, and Snore measures.
Safety: (more on this later).
Several Questions Remain
What about the safety data?
Ten patients (8.7%) experienced serious adverse events; the text of the article details each more. 3 (2.6%) required additional surgical intervention and removal; seven (6.1%) had diminished or loss of stimulation from device during monitoring. From the paper: “Ultimately, device- or procedure-related adverse events were experienced by 62.6% of participants with 59/210 (28.1%) non-serious events scored as moderate to severe in intensity (typically things like postoperative discomfort or brief tongue weakness). The majority (93.4%) of non-serious device- and procedure-related adverse events were self-limited and resolved within the first month of postoperative recovery.”These are roughly in line with initial STAR trial results from Inspire.
What is the experience and satisfaction with the device?
In the study population “After the 6-month study visit, fifty-six (48.7%) participants were deemed not yet optimized with treatment and went on to have 8- and 10-month PSGs.” This speaks to what we experience in ‘real world’ practice and is similar to Inspire: patients often require multiple touch points post-operatively with sleep teams and device reps to optimize settings.“Nightly usage was greater than 4 hours in more than 70% of nights in 84.3% (59/70) for participants completing diary entries in the 3 months preceding the 12-month visit. The device was used over 70% of the nights by 85.9% (61/71) of the participants.” So there is significant attrition from 115 patients to the numbers being measured for ongoing use, and the use was measured by diaries instead of objective data. The company monitored use with additional methods, but in review could only share this source-verified data. Additional objective use - including internal device clocking data - will be presented in follow up studies, and is felt to be encouraging.
Will Medicare and private payers waive DISE requirements long-term?
Inspire requires DISE preoperatively to exclude CCC. This study also used this inclusion criteria, though the company has posited that its bilateral stimulation design can achieve similar results in the CCC population. A separate trial (ACCCESS) focused on this is ongoing, we will await results.
What This Means for Clinicians & the Broader Sleep Field
This approval marks a significant expansion of HNS options in the U.S., offering an alternative to Inspire-only currently.
The surgical community now awaits acceptance from Medicare/insurers for coverage of the procedure. It is likely the company will need to significantly invest in the training/teaching of surgeons (similar to what Inspire needed to 10+ years ago) for the procedure before wider adoption.
Like its predecessor, there will need to be ongoing monitoring of device safety and its titration/use in the ‘real world’ setting.
🗨️ Over to you — How do you see Genio positioning against Inspire and other OSA treatment options? We’d love to hear your insights.
— Chris & Robson.