FDA product code EWO: Audiometer
EWO is the FDA product code for audiometer. It is a Class II device, regulated under 21 CFR 874.1050 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 235 510(k) submissions under EWO, 4 in the last five years, from 105 different applicants. The average 510(k) review took 103 days (median 85); 104 days on average over the last three years. FDA has posted 5 recalls for EWO devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Audiometer |
| Device class | Class II |
| Regulation | 21 CFR 874.1050 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for EWO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 85 |
| 2018 | 2 | 92 |
| 2019 | 1 | 54 |
| 2022 | 1 | 257 |
| 2023 | 1 | 150 |
| 2024 | 2 | 104 |
Compare with all 510(k) review times · Search every EWO clearance
Top EWO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Maico Hearing Instruments, Inc. | 20 | 1994-08-19 |
| Grason-Stadler, Inc. | 12 | 2018-05-11 |
| Bio-Logic Systems Corp. | 9 | 2012-11-01 |
| Otodynamics, Ltd. | 7 | 2024-03-15 |
| Tracor Instruments, Inc. | 7 | 1985-10-16 |
100 more applicants have EWO clearances. See the full list in Caduvo.
Most recent EWO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K234095 | Otodynamics | OtoNova/OtoNova Pro | 2024-06-21 | 178 |
| K240430 | Otodynamics, Ltd. | Otoport Pro | 2024-03-15 | 30 |
| K231545 | Hearx SA (Pty) , Ltd. | hearOAE | 2023-10-27 | 150 |
| K213345 | Path Medical GmbH | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | 2022-06-22 | 257 |
| K191372 | Interacoustics A/S | Lyra | 2019-07-15 | 54 |
Recalls for EWO devices
5 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-09-26.
| Year | Recalls |
|---|---|
| 2023 | 4 |
Frequently asked questions
What is FDA product code EWO?
EWO is the FDA product code for audiometer. It is a Class II device, regulated under 21 CFR 874.1050 and reviewed by the Ear, Nose and Throat panel.
What device class is EWO?
Class II, regulation 21 CFR 874.1050. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code EWO?
Across 235 cleared submissions the average was 103 days from receipt to decision (median 85).
Which companies have the most EWO clearances?
Maico Hearing Instruments, Inc. (20); Grason-Stadler, Inc. (12); Bio-Logic Systems Corp. (9); Otodynamics, Ltd. (7); Tracor Instruments, Inc. (7).
Have EWO devices been recalled?
Yes: 5 product recalls across 2 recall events; the most recent began 2023-09-26.
Next steps
- Run an FDA pathway report with predicate devices for product code EWO
- Run a recall and safety report across every EWO manufacturer
- Watch product code EWO 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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