Home › Device types › ESD
Hearing Aid, Air-Conduction, Prescription
FDA product code ESD · Class 1 · Ear, Nose, Throat
7,442
Registered devices
674
Adverse events
4
Recalls
1,367
510(k) clearances
Devices with this code
Biopor® AB light — Dreve Otoplastik GmbHAudio Service — Ws Audiology Usa, Inc.Oticon — Oticon A/SAudio Service — Ws Audiology Usa, Inc.Beltone — Gn Hearing A/SAudio Service — Ws Audiology Usa, Inc.Phonak — Phonak AGCapsure — HEARING LAB TECHNOLOGY, LLCGN Hearing — Gn Hearing A/SGN ReSound — Gn Hearing A/SAudio Service — Ws Audiology Usa, Inc.Audio Service — Ws Audiology Usa, Inc.Unitron — Unitron Hearing LtdAUDIOSYNC — Starkey Laboratories, Inc.GN Hearing — Gn Hearing A/SPhonak — Phonak AGAudina — Audina Hearing Instruments, Inc.STARKEY — Starkey Laboratories, Inc.Hansaton — Hansaton Akustik GmbHBeltone — Gn Hearing A/SPhonak Brand — Sonova AGAudio Service — Ws Audiology Usa, Inc.STARKEY — Starkey Laboratories, Inc.Miracle-Ear — 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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