FDA Device Intelligence
Home › Soundwave Hearing, LLC › Sontro Self-Fitting OTC Hearing Aids

Sontro Self-Fitting OTC Hearing Aids

Soundwave Hearing, LLC · Model 990002-SWH · UDI-DI 00850016231024

QUH
10
510(k) clearances
14
Adverse events
0
Recalls
30
Facilities

Description

GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.