FDA product code · Ear, Nose, Throat
EWOAudiometer
Product code EWO covers Audiometer, a Class II device regulated under 21 CFR 874.1050. FDA has cleared 235 devices in this code. Median review time across the 235 most recent decisions is 85 days. openFDA lists 5 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 874.1050
- Review panel
- Ear, Nose, Throat
- Clearances
- 235
What is happening in EWO right now?
EWO (Audiometer): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in EWO?
FDA has cleared 235 devices under product code EWO since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K234095 | OtoNova/OtoNova Pro | Otodynamics | |
| K240430 | Otoport Pro | Otodynamics, Ltd. | |
| K231545 | hearOAE | Hearx SA (Pty) , Ltd. | |
| K213345 | Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE | Path Medical GmbH | |
| K191372 | Lyra | Interacoustics A/S | |
| K180287 | GSI Corti | Grason-Stadler, Inc. | |
| K173567 | Sera | Interacoustics A/S | |
| K172403 | GSI Novus | Grason-Stadler, Inc. | |
| K171506 | Easyscreen | Maico Diagnostics GmbH | |
| K151025 | iHearTest | Ihear Medical, Inc. |
How long does FDA review take for EWO?
The median FDA review time for EWO is 85 days, measured across the 235 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EWO?
openFDA lists 5 recall records against product code EWO. A recall record covers one firm's corrective action and may span many device lots.
Z-0401-2024Open, ClassifiedPATH
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0402-2024Open, ClassifiedPATH
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0403-2024Open, ClassifiedPATH
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0404-2024Open, ClassifiedPATH
Affected lots of product may experience technical distortions to a greater extent than expected.
Z-0195-2009TerminatedCardinal Health
GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Correction: GSI Audera units with version 2.6 software may mislabel Auditory Evoked Potential (AEP) waveform responses with respect to the identification of the stimulus ear. When using 2.6 software in split-screen mod
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EWO?
MAUDE holds 20 adverse-event reports naming product code EWO, 10 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in EWO unusual?
EWO does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
10 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
What are the predicate devices in EWO?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EWO?
Across the 235 most recent decisions, these applicants filed most often in EWO.
| Applicant | Recent clearances |
|---|---|
| Maico Hearing Instruments, Inc. | 20 |
| Grason-Stadler, Inc. | 12 |
| Bio-Logic Systems Corp. | 9 |
| Otodynamics, Ltd. | 7 |
| Tracor Instruments, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in EWO file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Etymotic Research, Inc. | 8 | 2 |
| Otodynamics, Ltd. | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch EWO
Get an email the morning anything changes in EWO — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.