FDA product code · Ear, Nose, Throat
ESDHearing Aid, Air-Conduction, Prescription
Product code ESD covers Hearing Aid, Air-Conduction, Prescription, a Class I device regulated under 21 CFR 874.3300. FDA has cleared 1,367 devices in this code. Median review time across the 1,367 most recent decisions is 42 days. openFDA lists 4 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 874.3300
- Review panel
- Ear, Nose, Throat
- Clearances
- 1,367
What is happening in ESD right now?
ESD (Hearing Aid, Air-Conduction, Prescription): 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.
What does product code ESD cover?
ESD is FDA's product code for Hearing Aid, Air-Conduction, Prescription, a Class I device regulated under 21 CFR 874.3300.
An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid.
Source: openFDA device/classification · record ESD · retrieved
How many devices has FDA cleared in ESD?
FDA has cleared 1,367 devices under product code ESD since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232999 | Lyric4 Hearing Aid | Sonova AG | |
| K130790 | LYRIC2 | Phonak, LLC | |
| K081136 | LYRIC HEARING AID | Insound Medical, Inc. | |
| K021867 | INSOUND XT SERIES HEARING AID | Insound Medical, Inc. | |
| K003558 | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | Siemens Hearing Instruments, Inc. | |
| K984518 | SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL | Sonic Innovations, Inc. | |
| K974751 | TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC | General Hearing Instruments, Inc. | |
| K974242 | ARGOSY PROGRAMMABLE ONQUE | Argosy Electronics | |
| K973880 | SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM | Sonix Technologies, Inc. | |
| K974211 | OPUS 2 - FULL CONCHA SERIES - ITE | Bernafon-Maico, Inc. |
How long does FDA review take for ESD?
The median FDA review time for ESD is 42 days, measured across the 1,367 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 ESD?
openFDA lists 4 recall records against product code ESD. A recall record covers one firm's corrective action and may span many device lots.
Z-0583-2020TerminatedGN Hearing A/S
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.
Z-0584-2020TerminatedGN Hearing A/S
GN Hearing received reports from our manufacturing site in US regarding a software bug in our service & repair tool which affected the capture and restoration of user data in a limited number of repaired hearing aids. The software bug caused these repaired hearing aids to contain altered specifications for sound amplification, potentially putting users residual hearing at risk of experiencing unintended additional available gain to varying degrees i.a.18dB flat linear gain or potentially in worst case Full On Gain. However, no injuries have been reported.
Z-0094-2019TerminatedWidex A/S
The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.
Z-1681-2010TerminatedInsound Medical, Inc.
Manufacturing error could result in electrolyte leakage from the product's battery.
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 ESD?
MAUDE holds 76 adverse-event reports naming product code ESD, 37 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 ESD unusual?
ESD 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | 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 | |
| 1 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 7 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 9 | 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 |
22 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 ESD?
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 ESD?
Across the 1,367 most recent decisions, these applicants filed most often in ESD.
| Applicant | Recent clearances |
|---|---|
| Unitron Industries, Inc. | 69 |
| Miracle-Ear, Inc. | 64 |
| Electone, Inc. | 63 |
| Oticon Corp. | 54 |
| Widex Hearing Aid Co., Inc. | 51 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in ESD files 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 |
|---|---|---|
| Oticon Corp. | 63 | 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 ESD
Get an email the morning anything changes in ESD — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Ear, Nose, Throat
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.