Data / Medical devices / United States / Hearing Lab Technology, LLC
Hearing Lab Technology, LLC: FDA-registered device maker in Fort Worth, TX, United States, 1 510(k) clearance
Hearing Lab Technology, LLC is registered with the FDA (registration 3012213704) in Fort Worth, TX, United States. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 18, 1993. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012213704
- Address
- 14301 FAA Blvd Suite 105, Fort Worth, TX, United States, 76155
- Owner or operator
- Hearing Lab Technology, LLC (10052054)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- June 8, 2016
- Registered through
- 2026
- Brand names listed
- Accent, America Hears, Aspire, Assure, Capsure, ER-3A Insert Earphones, ER-3C Insert Earphones, ER3-14 Eartips and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Cushion, Earphone (For Audiometric Testing) | ETT | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Prescription | ESD | 1 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 18, 1993 | K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | EWO | Substantially Equivalent | Etymotic Research | accessdata.fda.gov |
Compare with other makers
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, Prescription
- All makers of Cushion, Earphone (For Audiometric Testing)
- All makers of Hearing Aid, Air-Conduction, Prescription
- All makers of Audiometer
- All makers of Hearing Aid, Air-Conduction, Over The Counter
Updated June 18, 1993. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.