Hearing Aid, S-522 FM
FDA 510(k) K760215 · Vicon Instrument Co.
510(k) numberK760215
Submission
- Device name
- Hearing Aid, S-522 FM
- Applicant
- Vicon Instrument Co.
Mchenry, IL, US - Received
- July 12, 1976
- Decision date
- July 21, 1976
- 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 |
|---|---|---|
| K811751 | Finetone Model Vi Hearing AidESD · Traditional | 07/15/1981SE |
| K790878 | Screening Audiometer, High FrequencyEWO · Traditional | 08/03/1979SE |
| K790064 | Tinnitus DevicesETS · Traditional | 02/16/1979SE |
| K771769 | Tinnitus Maskers, Models S564&S574KLW · Traditional | 01/03/1978SE |
| K771762 | Modular Hearing Device, Model S291ESD · Traditional | 10/04/1977SE |
| K770938 | Tinnitus Aid, Model S244KLW · Traditional | 06/28/1977SE |
| K761216 | Hearing Aids (Model E-552 S-712)ESD · Traditional | 12/16/1976SE |
Questions and answers
When was Hearing Aid, S-522 FM cleared by the FDA?
Hearing Aid, S-522 FM (K760215) received a 510(k) decision of Substantially Equivalent on July 21, 1976, 9 days after the submission was received.
What is the product code of K760215?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.