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Soundwave Hearing

Soundwave Hearing, LLC · Model 991011-SWH · UDI-DI 00850016231291

QUH
10
510(k) clearances
14
Adverse events
0
Recalls
28
Facilities

Description

OPEN-MEDIUM/991011-SWH; 10-pc blister pack of replacement ear domes for RIC used on Sontro Self-Fitting OTC Hearing Aids

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.