Table S4.

Therapy-related adverse events by severity

Severity	Adverse Event	No. subjects with event
Mild	Skin irritation (soreness, itchiness)	3
Mild	Nausea/vomiting	1
Mild	Tongue soreness	1
Mild	Pain or discomfort due to electrical stimulation	1
Mild	Change in salivary flow	1
Mild	Tongue abrasion with or without visible lesion(s)	4
Total with at least 1 mild adverse event		9/21
Moderate	Pain	1
Moderate	Tongue muscle fatigue, weakness or soreness	3
Moderate	Tongue abrasion with or without visible lesion(s)	8
Moderate	Bruising	1
Moderate	Lip Weakness	1
Moderate	Genitourinary abnormality	1
Moderate	Abnormal scarring (keloid or hypertrophic)	1
Moderate	Musculoskeletal abnormality	1
Total with at least 1 moderate adverse event		9/21
Severe	Infection*	1
Severe	Cuff dislodgement*	1
Total with at least 1 severe adverse event		2/21

Adverse events determined by the Clinical Events Committee to be related to HGNS therapy. Totals refer to number of patients with an event (i.e., one subject may have had > 1 event of a given severity).

^*Serious adverse event, also considered to be related to the implant procedure.