Data / Medical devices / United States / Etymotic Research, Inc.
Etymotic Research, Inc.: FDA-registered device maker in Schaumburg, IL, United States, 1 510(k) clearance
Etymotic Research, Inc. is registered with the FDA (registration 1450042) in Schaumburg, IL, United States. It lists 5 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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1450042
- Address
- 1125 Remington Road, Schaumburg, IL, United States, 60173
- Owner or operator
- ETYMOTIC RESEARCH, INC. (1450042)
- Roles
- Specification developer
- First device listed
- June 15, 1992
- Registered through
- 2026
- Brand names listed
- Accent, ER-3A Insert Earphones, ER-3C Insert Earphones, ER3-14 Eartips, ER38-14 Eartips, ER38-15 Eartips, ER38-18 Eartips, Enlite, Home Hearing Test, Lucid Portable Charging Case, Lucid Rechargeable Battery Module and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Audiometer | EWO | 2 | Specification developer | accessdata.fda.gov |
| Cushion, Earphone (For Audiometric Testing) | ETT | 1 | Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Prescription | OSM | 2 | Specification developer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction, Over The Counter | QUF | 1 | 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, 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 Audiometer
- All makers of Hearing Aid, Air-Conduction With Wireless Technology, 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.