Widex Hearing Aid #G2H & G2T
FDA 510(k) K830465 · Widex Hearing Aid Co., Inc.
510(k) numberK830465
Submission
- Device name
- Widex Hearing Aid #G2H & G2T
- Applicant
- Widex Hearing Aid Co., Inc.
Mchenry, IL, US - Received
- February 15, 1983
- Decision date
- May 9, 1983
- 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 |
|---|---|---|
| K080955 | Zen Program (Mind 440 Hearing Aid)KLW · Traditional | 06/27/2008SE |
| K971535 | Widex Senso Digital (Mini Canal)ESD · Traditional | 06/06/1997SE |
| K970904 | Widex Senso Digital (Cic)ESD · Traditional | 03/26/1997SE |
| K965254 | Widex Model Senso Digital (C9)ESD · Traditional | 03/12/1997SE |
| K965218 | Senso Digital (C18)ESD · Traditional | 01/24/1997SE |
| K955879 | Widex Model Senso Digital (C16)ESD · Traditional | 02/27/1996SE |
| K955878 | Widex Model Senso Digital (C8)ESD · Traditional | 02/12/1996SE |
| K954526 | Widex Senso Digital (PX)ESD · Traditional | 10/18/1995SE |
| K952229 | Widex Model Logo 32 (L32)ESD · Traditional | 06/19/1995SE |
| K946071 | Lx-ItcESD · Traditional | 01/30/1995SE |
Questions and answers
When was Widex Hearing Aid #G2H & G2T cleared by the FDA?
Widex Hearing Aid #G2H & G2T (K830465) received a 510(k) decision of Substantially Equivalent on May 9, 1983, 83 days after the submission was received.
What is the product code of K830465?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.