FDA.reportPublic FDA data

SOUNDWAVE HEARING, LLC

Matched from indexed company URL: Soundwave Hearing, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30155279833015527983SOUNDWAVE HEARING, LLC1N2026-01-01619 Enterprise Dr Ste 205 Oak Brook IL US 60523

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850016231000Sontro Self-Fitting OTC Hearing Aids - GREY/990030-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model AI-S); self-fit, streaming, app-controlled hearing aids833-367-4327support@hearsoundwave.com
00850016231024Sontro Self-Fitting OTC Hearing Aids - GREY/990002-SWH; set of Sontro Self-Fitting OTC Hearing Aids (Model: AI); self-fit, app-controlled hearing aids833-367-4327support@hearsoundwave.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2291891323139393K231550Sontro® OTC Hearing Aids (AI)QUH2023-10-26
2291891013047704
2291891787912084

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
QUH12023-10-26

PMN#

GUDID#