Program 3-CH Ser Hear Aids W/Program Fit Syst/Pro Fit
FDA 510(k) K944078 · Argosy Electronics
510(k) numberK944078
Submission
- Device name
- Program 3-CH Ser Hear Aids W/Program Fit Syst/Pro Fit
- Applicant
- Argosy Electronics
Eden Prairie, MN, US - Received
- August 22, 1994
- Decision date
- October 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K974242 | Argosy Programmable OnqueESD · Traditional | 01/20/1998SE |
| K971699 | Argosy DynameqESD · Traditional | 07/03/1997SE |
| K961729 | Argosy ProgrammableESD · Traditional | 05/29/1996SE |
| K954038 | K-Amp 16, Hi-Band K-Amp, Ultra Compression & Hearing Protection/Hearing InstrumentESD · Traditional | 09/18/1995SE |
| K952452 | Output Compression Limiter with Active Tone ControlESD · Traditional | 07/06/1995SE |
| K952451 | Class D Linear with Active Tone ControlESD · Traditional | 07/06/1995SE |
| K952450 | Wide Dynamic Range Compression with Active Tone ControlESD · Traditional | 07/06/1995SE |
| K952455 | Improved Manhattan IIESD · Traditional | 06/21/1995SE |
| K952454 | Expander with Active Tone ControlESD · Traditional | 06/21/1995SE |
| K952453 | Input Comprssion Limiter with Active Tone ControlESD · Traditional | 06/21/1995SE |
Questions and answers
When was Program 3-CH Ser Hear Aids W/Program Fit Syst/Pro Fit cleared by the FDA?
Program 3-CH Ser Hear Aids W/Program Fit Syst/Pro Fit (K944078) received a 510(k) decision of Substantially Equivalent on October 21, 1994, 60 days after the submission was received.
What is the product code of K944078?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.