Sparrow Ascent

The Sparrow Ascent is a transcutaneous auricular neurostimulation device that delivers mild electrical stimulation to nerves around the ear to reduce opioid withdrawal symptoms in adult patients. It is used in clinical settings and at home under supervision of trained clinical personnel, in conjunction with standard symptomatic medications and other withdrawal therapies.

The subject device is identical to the predicate (K230796) except for earpiece electrode placement: the subject uses a mastoid electrode while the predicate uses a cymba concha electrode. Both deliver identical electrical outputs (max 5.0 mA, 750 µs pulse width, 150 Hz frequency). Materials and device principle of operation remain unchanged, with equivalent ratios of patient-contacting materials despite reduced earpiece size.

Not stated in this summary.

The device achieves substantial equivalence through: (1) identical indications for use with the predicate; (2) fMRI clinical data demonstrating equivalent spatial brain activation patterns between mastoid and cymba concha stimulation sites (r=0.61, p<0.001); (3) identical electrical output parameters; (4) non-clinical verification testing confirming the device operates as expected; and (5) comparison to a reference device (NET Device, K233166) showing similar current density and power density, supporting equivalent effectiveness and safety despite the electrode location change.