Post-Auricular Hearing Aid (#PE830)
FDA 510(k) K810030 · Hc Electronics
510(k) numberK810030
Submission
- Device name
- Post-Auricular Hearing Aid (#PE830)
- Applicant
- Hc Electronics
Mchenry, IL, US - Received
- January 6, 1981
- Decision date
- January 14, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ESD – Hearing Aid, Air-Conduction, Prescription
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.3300
- Specialty
- Ear, Nose, Throat
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.
Other 510(k)s with product code ESD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232999 | Lyric4 Hearing AidESD · Traditional | Sonova AG | 04/11/2024SE |
| K130790 | LYRIC2ESD · Traditional | Phonak, LLC | 06/27/2013SE |
| K081136 | Lyric Hearing AidESD · Traditional | Insound Medical, Inc. | 05/08/2008SE |
| K021867 | Insound XT Series Hearing AidESD · Traditional | Insound Medical, Inc. | 11/19/2002SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | Siemens Hearing Instruments, Inc. | 04/24/2001SE |
| K984518 | Sonic Innovations Completely-In-The-Canal DSP Hearing Aid with Soft ShellESD · Traditional | Sonic Innovations, Inc. | 03/12/1999SE |
| K974751 | Tranquil Tri-Oe, Tranquil Tri-Coe, Tranquil Tri-CicESD · Traditional | General Hearing Instruments, Inc. | 03/06/1998SE |
| K974242 | Argosy Programmable OnqueESD · Traditional | Argosy Electronics | 01/20/1998SE |
| K973880 | Sonix Hearing Aid Fitting and Programming SystemESD · Traditional | Sonix Technologies, Inc. | 01/12/1998SE |
| K974211 | Opus 2 - Full Concha Series - IteESD · Traditional | Bernafon-Maico, Inc. | 12/15/1997SE |
More from Bernafon-Maico, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K810031 | Stereo Auditory Trainer (Model PM228)EPF · Traditional | 03/04/1981SE |
| K800340 | Phonic Ear, Model 841LESD · Traditional | 02/26/1980SE |
| K782053 | Hearing Aid, Post-AuricularESD · Traditional | 12/15/1978SE |
| K780936 | Phonic EarEPF · Traditional | 06/22/1978SE |
| K780363 | Phonic EarESD · Traditional | 03/21/1978SE |
| K772347 | Phonic Mirror Handivoice Model 120 · Traditional | 01/11/1978SE |
| K772346 | Phonic Mirror Handivocie Model 110 · Traditional | 01/11/1978SE |
| K771357 | Group Auditory Trainer HC 431REPF · Traditional | 07/29/1977SE |
| K771356 | Post-Auricular Hearing Aid HC 880ESD · Traditional | 07/29/1977SE |
Questions and answers
When was Post-Auricular Hearing Aid (#PE830) cleared by the FDA?
Post-Auricular Hearing Aid (#PE830) (K810030) received a 510(k) decision of Substantially Equivalent on January 14, 1981, 8 days after the submission was received.
What is the product code of K810030?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.