Telex Tinnitus-Companion
FDA 510(k) K984243 · Telex Communications, Inc.
510(k) numberK984243
Submission
- Device name
- Telex Tinnitus-Companion
- Applicant
- Telex Communications, Inc.
Minneapolis, MN, US - Received
- November 27, 1998
- Decision date
- January 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KLW – Masker, Tinnitus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3400
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code KLW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260413 | Levo Gen 2 Tinnitus Therapy SystemKLW · Traditional | Levo Medical Corporation | 08/13/2026SE |
| K260614 | Tinnitus TherapyKLW · Special | Sivantos GmbH | 06/10/2026SE |
| K233435 | Peace N Quiet (0.7.0)KLW · Traditional | Pnq Health | 02/27/2024SE |
| K223694 | Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)KLW · Traditional | Duearity AB | 06/30/2023SE |
| K221168 | Tinnitogram Signal GeneratorKLW · Traditional | Goldenear Company, Inc. | 02/01/2023SE |
| K221125 | SilentCloudKLW · Traditional | Aureliym GmbH | 01/04/2023SE |
| K201370 | Multiflex Tinnitus TechnologyKLW · Special | Starkey Laboratories, Inc. | 06/19/2020SE |
| K193303 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 02/20/2020SE |
| K180495 | Tinnitus Sound Generator ModuleKLW · Traditional | GN Hearing A/S | 11/30/2018SE |
| K181586 | Tinnitus Sound Generator ModuleKLW · Special | GN Hearing A/S | 07/13/2018SE |
More from GN Hearing A/S
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K933095 | 351-AGCO Behind-The-Ear Hearing AidESD · Traditional | 07/26/1993SE |
Questions and answers
When was Telex Tinnitus-Companion cleared by the FDA?
Telex Tinnitus-Companion (K984243) received a 510(k) decision of Substantially Equivalent on January 21, 1999, 55 days after the submission was received.
What is the product code of K984243?
The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.