Behind-The-Ear Hearing Aid #8003
FDA 510(k) K823531 · Danavox, Inc.
510(k) numberK823531
Submission
- Device name
- Behind-The-Ear Hearing Aid #8003
- Applicant
- Danavox, Inc.
Mchenry, IL, US - Received
- November 29, 1982
- Decision date
- December 15, 1982
- 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 |
|---|---|---|
| K940608 | 155 PP Agc-IESD · Traditional | 05/04/1994SE |
| K851069 | Body Type Hearing Aid 107SESD · Traditional | 06/05/1985SE |
| K843791 | Behind-The-Ear 123 VTHESD · Traditional | 11/09/1984SE |
| K833486 | In-The-Ear Hearing Aid ModelESD · Traditional | 06/22/1984SE |
| K832751 | Behind-The-Ear Series 125ESD · Traditional | 09/29/1983SE |
| K832326 | Behind-The-Ear #123 AgciESD · Traditional | 09/29/1983SE |
| K823073 | 101M In-The-EarESD · Traditional | 01/07/1983SE |
| K822655 | Behind-The-Ear Model 115 V Agc O WESD · Traditional | 09/14/1982SE |
| K822619 | Behind-The-Ear Model 115PPPCWESD · Traditional | 09/14/1982SE |
| K822387 | Behind-The-Ear Model Series 123ESD · Traditional | 08/19/1982SE |
Questions and answers
When was Behind-The-Ear Hearing Aid #8003 cleared by the FDA?
Behind-The-Ear Hearing Aid #8003 (K823531) received a 510(k) decision of Substantially Equivalent on December 15, 1982, 16 days after the submission was received.
What is the product code of K823531?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.