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Sparrow Ascent Earpiece, Right

Spark Biomedical Inc. · Model 211 · UDI-DI 00850052017019

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510(k) clearances

Adverse events

Recalls

Facilities

Description

The Earpiece is a disposable component of the Sparrow Ascent and is designed to stay adhered to the skin of the left or right ear for up to 24 hours of electrical connectivity. The Inner Electrode interfaces with the cymba concha and the Outer Electrode interfaces with the trigeminal nerve. The Back Electrode is the return Electrode for both the Inner and Outer Electrodes.

Recalls

Date	Firm	Reason
2025-07-02	Spark Biomedical Inc	Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.