A phase IIb study in England investigated the effectiveness of a trigeminal nerve stimulation (TNS) device that was FDA approved in 2019 for children and adolescents with ADHD[7]. The research included 150 children and adolescents treated with this device[7]. The main finding of the study was that the FDA-cleared device was not shown to be effective in reducing ADHD symptoms[7]. The study thus questions the benefits of this method, which was previously considered a promising way to treat attention deficit hyperactivity disorder. The results indicate the need for further investigation of the safety and efficacy of devices intended for the treatment of ADHD before their clinical use. These findings highlight the importance of rigorous testing of treatment approaches before regulatory approval.