Custom Tci-Combi (Tinnitus Control Instrument Combination)
FDA 510(k) K011366 · Siemens Hearing Instruments, Inc.
510(k) numberK011366
Submission
- Device name
- Custom Tci-Combi (Tinnitus Control Instrument Combination)
- Applicant
- Siemens Hearing Instruments, Inc.
Piscataway, NJ, US - Received
- May 4, 2001
- Decision date
- June 1, 2001
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K071462 | Unity 2 Hia & Probe ( for Use with Unity 2)ETW · Traditional | 06/05/2007SE |
| K011364 | Custom Tci (Tinnitus Control Instrument)KLW · Traditional | 06/07/2001SE |
| K003559 | Tci (Tinnitus Control Instrument)KLW · Traditional | 04/26/2001SE |
| K003558 | Tci Combi (Tinnitus Control Instrument Combination)ESD · Traditional | 04/24/2001SE |
| K972998 | PrismaESD · Traditional | 09/05/1997SE |
| K962170 | Siemens Vita 160 Series Pocket Hearing Instrument: Vita 162E,166M,168PPESD · Traditional | 07/25/1996SE |
| K952940 | Personal Programmer 2000ESD · Traditional | 07/26/1995SE |
| K951828 | Full Dynamic Range Compression Behind the Ear Hearing InstrumentESD · Traditional | 06/30/1995SE |
| K952263 | Programmable Two Memory, Single Band Behind the Ear Hearing InstrumentESD · Traditional | 06/05/1995SE |
| K951896 | Intelivenience Programmable Full Dynamic Range Compression Behind the Ear Hearing…ESD · Traditional | 05/30/1995SE |
Questions and answers
When was Custom Tci-Combi (Tinnitus Control Instrument Combination) cleared by the FDA?
Custom Tci-Combi (Tinnitus Control Instrument Combination) (K011366) received a 510(k) decision of Substantially Equivalent on June 1, 2001, 28 days after the submission was received.
What is the product code of K011366?
The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.