This study represents the first multicenter, randomized, placebo‐controlled assessment of a medical device indicated for OM treatment.
For example, in the case of a device indicated for treatment-refractory depression, the randomised postapproval study showed no dose response for the treatment, leading to changes in the device labelling.
In Part 2 of this paper, we classify the electrical output performance of devices cleared by the United States Food and Drug Administration FDAA) including over-the-counter (OTC) and prescription electrostimulation devices, devices available for therapeutic or cosmetic purposes, and devices indicated for stimulation of the body or head.
In the current study forced calibration was not possible, calibration was only performed when the CGM device indicated the need for calibration by itself.
This device is indicated for the treatment of pertrochanteric and basicervical fractures with intact lateral walls (AO types 31A1,31A2,B2.1) [12] and is inserted by a minimally invasive technique which minimizes soft tissue damage and blood loss, retains the fracture haematoma and avoids excessive periosteal stripping.
The Wallis device is indicated for the treatment of low back pain associated with degenerative disc diseases as well as lateral recess and central spinal stenosis.
The Wallis device is indicated for mild lumbar stenosis, large disc herniation, recurrent disc herniation, and Modic type 1 changes with low back pain [ 6].
Moreover, other authors underlined that these patients do not represent the core of the indication spectrum for the OTSC closure clip, but, rather, is at the margin of what this device is indicated for.
We were unable to find evidence for the statement that the NTI-tss device was indicated for the prevention of bruxism, TMDs, chronic tension-type headaches, migraine, or occlusal trauma.
According to the manufacturer, the NTI-tss device is indicated for the prevention and treatment of bruxism, temporomandibular disorders (TMDs), occlusal trauma, tension-type headaches and/or migraine [ 1].
Thus, the possibility to change space perception and improve navigation by means of a relatively small and usable device indicates numerous starting points for scientists investigating limits and potentialities of sensory augmentation.
