Twenty-three patients experienced temporary tongue weakness after the surgery, which resolved in all of them. Nine patients began using a tooth guard to resolve tongue soreness or abrasion.
"This approach may not be appropriate for persons with excessive airway collapsibility," Dr. Strollo and his associates cautioned. They screened potential study participants using endoscopy during drug-induced sleep, to identify functional upper-airway collapse originating in the retrolingual region, which would be the most amenable to neurostimulation at the base of the tongue.
The FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations, and vote on information related to the premarket approval application on Feb. 20.