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government organization in the United States.
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Most common adverse events possibly or probably device related.
| Adverse event | n | % |
|---|---|---|
| Light headedness | 8/217 | 4% |
| Tingling | 7/217 | 3% |
| Ringing in ears (Tinnitus) | 7/217 | 3% |
| Dizziness | 6/217 | 3% |
| Headache | 5/217 | 2% |
| Scalp discomfort | 5/217 | 2% |
| Discomfort from noise | 5/217 | 2% |
| Any reported adverse events | 62/217 | 29% |
