FDA product code ESD: Hearing Aid, Air-Conduction, Prescription
ESD is the FDA product code for hearing aid, air-conduction, prescription. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 1,367 510(k) submissions under ESD, 1 in the last five years, from 260 different applicants. The average 510(k) review took 56 days (median 42); 202 days on average over the last three years. FDA has posted 4 recalls for ESD devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Hearing Aid, Air-Conduction, Prescription |
| Device class | Class I |
| Regulation | 21 CFR 874.3300 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Ear, Nose, Throat |
| Premarket route | 510(k) exempt |
510(k) clearances per year for ESD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2024 | 1 | 202 |
Compare with all 510(k) review times · Search every ESD clearance
Top ESD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unitron Industries, Inc. | 69 | 1997-12-12 |
| Miracle-Ear, Inc. | 64 | 1997-07-23 |
| Electone, Inc. | 63 | 1997-09-23 |
| Oticon Corp. | 54 | 1996-11-27 |
| Widex Hearing Aid Co., Inc. | 51 | 1997-06-06 |
255 more applicants have ESD clearances. See the full list in Caduvo.
Most recent ESD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K232999 | Sonova AG | Lyric4 Hearing Aid | 2024-04-11 | 202 |
| K130790 | Phonak, LLC | LYRIC2 | 2013-06-27 | 97 |
| K081136 | Insound Medical, Inc. | LYRIC HEARING AID | 2008-05-08 | 17 |
| K021867 | Insound Medical, Inc. | INSOUND XT SERIES HEARING AID | 2002-11-19 | 166 |
| K003558 | Siemens Hearing Instruments, Inc. | TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION) | 2001-04-24 | 158 |
Recalls for ESD devices
4 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-09-18.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 2 |
Frequently asked questions
What is FDA product code ESD?
ESD is the FDA product code for hearing aid, air-conduction, prescription. It is a Class I device, regulated under 21 CFR 874.3300 and reviewed by the Ear, Nose and Throat panel.
What device class is ESD?
Class I, regulation 21 CFR 874.3300. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code ESD?
Across 1,367 cleared submissions the average was 56 days from receipt to decision (median 42).
Which companies have the most ESD clearances?
Unitron Industries, Inc. (69); Miracle-Ear, Inc. (64); Electone, Inc. (63); Oticon Corp. (54); Widex Hearing Aid Co., Inc. (51).
Have ESD devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2019-09-18.
Next steps
- Run an FDA pathway report with predicate devices for product code ESD
- Run a recall and safety report across every ESD manufacturer
- Watch product code ESD 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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