Model 350 Wireless Bicros/Multicros Hearing Aids
FDA 510(k) K870434 · Telex Communications, Inc.
510(k) numberK870434
Submission
- Device name
- Model 350 Wireless Bicros/Multicros Hearing Aids
- Applicant
- Telex Communications, Inc.
Minneapolis, MN, US - Received
- February 3, 1987
- Decision date
- March 11, 1987
- 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 |
|---|---|---|
| K984243 | Telex Tinnitus-CompanionKLW · Traditional | 01/21/1999SE |
| K982683 | Telex Select 1-40 with Adaptive CompressionEPF · Traditional | 10/06/1998SE |
| K964639 | Telex In-The-Ear Custom Hearing Aid with Threshold Compression-IiESD · Traditional | 01/21/1997SE |
| K963915 | Telex In-The-Ear Custom Hearing Aid with Threshold CompressionESD · Traditional | 11/08/1996SE |
| K961143 | Telex Select 2-40 with Adaptive Compression S2-40ESD · Traditional | 05/07/1996SE |
| K954579 | Telex 349 Multi Cros W/Adapive CompressionESD · Traditional | 12/08/1995SE |
| K943961 | The Model Acappella in the Ear Hearing AidESD · Traditional | 05/15/1995SE |
| K935048 | Artisan Programmer & Hearing AidLRB · Traditional | 02/09/1994SE |
| K935366 | Binaural Hearing AidESD · Traditional | 01/13/1994SE |
| K933579 | Memorex Artisan System/Artisan Programmer and Custom Hearing AidESD · Traditional | 08/23/1993SE |
Questions and answers
When was Model 350 Wireless Bicros/Multicros Hearing Aids cleared by the FDA?
Model 350 Wireless Bicros/Multicros Hearing Aids (K870434) received a 510(k) decision of Substantially Equivalent on March 11, 1987, 36 days after the submission was received.
What is the product code of K870434?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.