SOUNDWAVE HEARING, LLC

FDA Device Registration & Listing · Oak Brook, IL, US · Registration 3015527983

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3015527983
FEI Number
3015527983
Entity Name
SOUNDWAVE HEARING, LLC
City/State/Country
Oak Brook, IL, US
Establishment Address
619 Enterprise Dr Ste 205, Oak Brook, IL 60523, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Soundwave Hearing, LLC (Owner Number: 10060266)
Owner / Operator Contact Address
619 Enterprise Dr Ste 205, Oak Brook, IL 60523, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K231550
PMA Number
N/A

All Registered Proprietary Names

Accessory-Sport Lock Accessory-Ear Dome otoTune app (for Android) Sontro Self-Fitting OTC Hearing Aids otoTune app (for iOS) Accessory-Receiver-In-Canal

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QUH Self-Fitting Air-Conduction Hearing Aid, Over The Counter Ear, Nose, Throat Class 2 874.3325 2023-11-05

Official Correspondent

Anthony Florek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Soundwave Hearing, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Similar Registrations

Registration Number Establishment Name Location
3023339161 TUNED LTD Gan Yoshiya Central, IL
3040068315 LUXSHARE ELECTRONIC TECHNOLOGY (KUNSHAN) LTD. Kunshan Jiangsu, CN
3014337591 HEARX SA Pretoria Gauteng, ZA
3010841212 EARGO INC San Jose, CA, US
2182204 GN Hearing Care Corporation Shakopee, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015527983. Last updated year: 2026. Please use registration number 3015527983 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.