Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012213704

FEI Number

3012213704

Entity Name

HEARING LAB TECHNOLOGY, LLC

City/State/Country

Fort Worth, TX, US

Establishment Address

14301 FAA Blvd, Suite 105, Fort Worth, TX 76155, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Repack or Relabel Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Hearing Lab Technology, LLC (Owner Number: 10052054)

Owner / Operator Contact Address

14301 FAA Blvd, Suite 105, Suite A, Fort Worth, TX 76155, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K930003

PMA Number

N/A

All Registered Proprietary Names

Elevate Engage Assure Liberty Liberty Engage Member's Selection Walker's America Hears Capsure Aspire Present Accent Freedom Ear Back Hearing Aid Model 456 Ear Back Hearing Aid Model 256 Ear Back Hearing Aid Model 556 Ear Back Hearing Aid Model 546 Ear Back Hearing Aid Model 557 Ear Back Hearing Aid Model 446 Ear Back Hearing Aid Model 756 Ear Back Hearing Aid Model 246 Ear Back Hearing Aid Model 746 Renew ER38-15 Eartips ER38-14 Eartips ER3-14 Eartips ER38-18 Eartips Enrich, Enrich Pro, Enlite, Enlite Plus Tala Engage, Engage Rechargeable, Fio Engage Assure Elevate Liberty Walker's Accent Member's Selection America Hears Present Aspire Liberty Engage Freedom Capsure Fio ER-3A Insert Earphones ER-3C Insert Earphones

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OSM	Hearing Aid, Air-Conduction With Wireless Technology, Prescription	Ear, Nose, Throat	Class 2	874.3305	2016-06-08
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	Class 1	874.1100	2022-06-30
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2022-10-20
QUG	Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter	Ear, Nose, Throat	Class 2	874.3305	2022-10-20
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2016-06-08
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2022-06-30

Official Correspondent

Susan Reid

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hearing Lab Technology, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2523532	Hearing Lab Technology, LLC.	West Bristol, PA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30
K946253	Maico Hearing Instruments, Inc.	MAICO IN-THE-EAR MODEL RD 201	1995-01-30
K863975	Gn Danavox, Inc.	CUSTOM IN-THE-EAR	1986-11-07

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012213704. Last updated year: 2026. Please use registration number 3012213704 when referencing this establishment in official correspondence.