Telstar Model 1/3 Ite Hearing Aid
FDA 510(k) K892457 · Telstar Electronics, Inc.
510(k) numberK892457
Submission
- Device name
- Telstar Model 1/3 Ite Hearing Aid
- Applicant
- Telstar Electronics, Inc.
Winter Springs, FL, US - Received
- April 10, 1989
- Decision date
- June 6, 1989
- 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 |
|---|---|---|
| K892460 | Telstar Model PP Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K892459 | Telstar Model C Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K892458 | Telstar Model F Ite Hearing AidESD · Traditional | 06/06/1989SE |
| K871731 | Telstar Prewire SeriesLRS · Traditional | 10/27/1987SE |
| K873210 | Telstar Model PPESD · Traditional | 09/29/1987SE |
| K871520 | Telstar Model FS Hearing AidESD · Traditional | 06/08/1987SE |
| K871522 | Telstar Model C Hearing AidESD · Traditional | 06/05/1987SE |
| K871521 | Full Shell Ite Hearing AidESD · Traditional | 06/05/1987SE |
| K871518 | Telstar Model F3TS Hearing AidESD · Traditional | 06/05/1987SE |
| K871519 | Telstar Model 0/3 Hearing AidESD · Traditional | 05/19/1987SE |
Questions and answers
When was Telstar Model 1/3 Ite Hearing Aid cleared by the FDA?
Telstar Model 1/3 Ite Hearing Aid (K892457) received a 510(k) decision of Substantially Equivalent on June 6, 1989, 57 days after the submission was received.
What is the product code of K892457?
The FDA product code is ESD – Hearing Aid, Air-Conduction, Prescription, a Class I (low risk) device regulated under 21 CFR 874.3300.