Problem solving
HYPNARA™, MORPHEX™AI and related technologies are not yet FDA cleared or approved and not currently available for sale.
Who we serve
Supporting patients, clinicians, and partners shaping the future of mask-free sleep apnea care.
Why us
Reference
Clinical Background
Palatal implants have been evaluated as a minimally invasive option to stiffen the soft palate and reduce snoring and certain symptoms of sleep‑disordered breathing in appropriately selected adults. The studies listed below report outcomes with a previously FDA‑cleared palatal implant system (often referred to as the Pillar procedure) and are provided solely as scientific background on this therapeutic approach.
Published Evidence
Multiple prospective and randomized studies of this predicate device have shown reductions in snoring severity scores, improvements in bed‑partner‑reported symptoms, and, in some cohorts, improvements in apnea–hypopnea index and daytime sleepiness measures. As with all medical procedures, results varied across studies and patients, and not all individuals experienced clinically meaningful benefit.
Regulatory Clarification
These publications do not contain data on Somnus products. Any mention of palatal implants on this page refers to the predicate devices evaluated in the cited literature and not to Somnus devices. Inclusion of these references is not intended to imply that similar outcomes would be observed with Somnus products or that Somnus products have been determined to be safe or effective for any indication.
