FDA product code ETW: Calibrator, Hearing Aid / Earphone And Analysis Systems
ETW is the FDA product code for calibrator, hearing aid / earphone and analysis systems. It is a Class II device, regulated under 21 CFR 874.3310 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 46 510(k) submissions under ETW, from 25 different applicants. The average 510(k) review took 76 days (median 69).
Classification
| Field | Value |
|---|---|
| Device name | Calibrator, Hearing Aid / Earphone And Analysis Systems |
| Device class | Class II |
| Regulation | 21 CFR 874.3310 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every ETW clearance
Top ETW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Frye Electronics, Inc. | 9 | 2009-12-30 |
| Starkey Laboratories, Inc. | 4 | 1994-10-21 |
| Madsen Electronics (Canada) , Ltd. | 4 | 1989-02-13 |
| Rastronics USA, Inc. | 3 | 1990-10-05 |
| Gn Otometrics A/S | 2 | 2011-04-28 |
20 more applicants have ETW clearances. See the full list in Caduvo.
Most recent ETW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122028 | Gn Otometrics | AURICAL HIT | 2012-10-23 | 105 |
| K113831 | Auditdata A/S | PRIMUS HEARING INSTRUMENT TEST UNIT | 2012-04-19 | 114 |
| K110286 | Gn Otometrics A/S | GN OTOMETRICS TYPE 1053 FREEFIT | 2011-04-28 | 87 |
| K093006 | Frye Electronics, Inc. | FONIX ,MODEL 8000 | 2009-12-30 | 93 |
| K071462 | Siemens Hearing Instruments, Inc. | UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) | 2007-06-05 | 11 |
Recalls for ETW devices
openFDA lists no recalls for product code ETW.
Frequently asked questions
What is FDA product code ETW?
ETW is the FDA product code for calibrator, hearing aid / earphone and analysis systems. It is a Class II device, regulated under 21 CFR 874.3310 and reviewed by the Ear, Nose and Throat panel.
What device class is ETW?
Class II, regulation 21 CFR 874.3310. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ETW?
Across 46 cleared submissions the average was 76 days from receipt to decision (median 69).
Which companies have the most ETW clearances?
Frye Electronics, Inc. (9); Starkey Laboratories, Inc. (4); Madsen Electronics (Canada) , Ltd. (4); Rastronics USA, Inc. (3); Gn Otometrics A/S (2).
Next steps
- Run an FDA pathway report with predicate devices for product code ETW
- Run a recall and safety report across every ETW manufacturer
- Watch product code ETW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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