Summary The Fisher Wallace Stimulator, a cranial electrical stimulator (CES) headband, has been used to treat insomnia, anxiety, and depression. It was previously known as the LISS Cranial Stimulator which was FDA cleared in 1990 to treat insomnia and/or anxiety, and the company is [...]
Summary There are both adult (Restore 1 and 2) and pediatric (Rest Go, Rest 2nd gen, Rest + 2nd gen) Hatch products. All are (sound, light, and alarm) nearables with apps. Hatch Restore 1 offers music, sounds, stories, mind/body exercises, bedside lighting, and light [...]
Summary URGOnight consists of a wearable EEG headband connected to an app via Bluetooth. URGOnight has two dry measuring electrodes over the sensorimotor cortex in positions C3 and C4, with reference and ground positioned on the left and right mastoids. The headband EEG data [...]
Summary Modius Sleep is a prescription headset for adult insomnia treatment. It resembles a headband across the top of the head, with wires which are applied over the mastoid bone bilaterally. Users are recommended to sit in a chair at approximately 8-9pm (bedtime 1-5 [...]
Summary There is a small hand held base unit, to which 2 lead wires are attached. These lead wires attach to ear clips. The user applies a drop of saline to each ear clip before clipping each earlobe. The first 30 days protocol includes [...]
Summary Somnee, an electronic sleep aid headband, is worn for 15 minutes before bedtime while reportedly delivering personalized transcranial alternating current stimulation. The device purportedly uses proprietary EEG+ technology to read the user’s EEG patterns and personalize the neuromodulation (tACS) delivery. The 15-minutes pre-bedtime [...]
Summary Headspace app allows the user to access meditation and mindfulness exercises, sleepcasts, and educational materials with the goal to alleviate stress, anxiety, and insomnia. There are 5 sections: Today (personalized content), Meditate (one-off or muliti-part course guided meditations), Sleep (guided meditations, stories, relaxing [...]
Summary The HoneyNaps platform includes SOMNUM, an AI software as a medical device (SaMD) that is FDA cleared (8/16/23), My SOMNUM, a non-contact nearable that includes sleep analysis and coaching, and SOMNUM Medella, a digital treatment for insomnia. SOMNUM software is FDA cleared for [...]
Summary Available information is limited at this time as to the over-the counter Galaxy watch sensors and proprietary algorithms. The Apnea Feature which assesses “risk of sleep apnea” (over a 2 night period for adults at least 22 years old) received FDA Granted status [...]
Summary Somnio Insomnia Therapy is an online, self-directed, 8-session course focused on improving the user’s sleep pattern and sleep environment, identifying and adjusting lifestyle habits, learning to recognize and change negative beliefs and thoughts, reinforcing positive beliefs and thoughts, and learning techniques that help [...]