Home › Device types › ESD
Hearing Aid, Air-Conduction, Prescription
FDA product code ESD · Class 1 · Ear, Nose, Throat
7,440
Registered devices
673
Adverse events
4
Recalls
1,367
510(k) clearances
Devices with this code
Arc tubing connection — Dreve Otoplastik GmbHAudina — Audina Hearing Instruments, Inc.PRO3DURE GR-10 — pro3dure medical GmbHAudio Service — Ws Audiology Usa, Inc.STARKEY — Starkey Laboratories, Inc.Audio Service — Ws Audiology Usa, Inc.audifon — audifon GmbH & Co. KGPhonak — Phonak AGluxaprint shellac color green 50 ml — DETAX GmbHAspire — HEARING LAB TECHNOLOGY, LLCNewsound — Xiamen New Sound Technology Co., Ltd.Audio Service — Ws Audiology Usa, Inc.Biopor® AB fluoreszent — Dreve Otoplastik GmbHAudio Service — Ws Audiology Usa, Inc.Beltone — Gn Hearing A/SNUEAR — Starkey Laboratories, Inc.Siemens — Ws Audiology Usa, Inc.Sonic — Sonic Innovations, Inc.Biopor® AB light — Dreve Otoplastik GmbHAudio Service — Ws Audiology Usa, Inc.Unitron — Unitron Hearing LtdSiemens — Ws Audiology Usa, Inc.Coselgi — Widex A/SAudio Service — Ws Audiology Usa, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-09-18 | GN 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 o |
| 2019-09-18 | GN 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 o |
| 2018-08-31 | Widex 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 d |
| 2010-01-19 | InSound Medical, Inc. | Manufacturing error could result in electrolyte leakage from the product's battery. |
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