Phonak Tinnitus Balance
FDA 510(k) K123450 · Phonak, LLC
510(k) numberK123450
Submission
- Device name
- Phonak Tinnitus Balance
- Applicant
- Phonak, LLC
Warrenville, IL, US - Received
- November 9, 2012
- Decision date
- February 11, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
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| K130790 | LYRIC2ESD · Traditional | 06/27/2013SE |
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| K972105 | Phonak EpicaESD · Traditional | 08/01/1997SE |
| K972097 | Phonak Microzoom P 2ESD · Traditional | 07/30/1997SE |
| K964035 | Phonak Microlink, Personal FM ReceiverESD · Traditional | 12/04/1996SE |
| K961653 | Phonak Sona P2ESD · Traditional | 05/29/1996SE |
| K961622 | Phonak PICONET2 P2 AzESD · Traditional | 05/17/1996SE |
| K953921 | Phonak 9900 CicESD · Traditional | 09/18/1995SE |
| K945439 | Phonak Piconet 232X-AZ Hearing InstrumentESD · Traditional | 08/23/1995SE |
| K950758 | Dyna 231XESD · Traditional | 03/21/1995SE |
Questions and answers
When was Phonak Tinnitus Balance cleared by the FDA?
Phonak Tinnitus Balance (K123450) received a 510(k) decision of Substantially Equivalent on February 11, 2013, 94 days after the submission was received.
What is the product code of K123450?
The FDA product code is KLW – Masker, Tinnitus, a Class II (moderate risk) device regulated under 21 CFR 874.3400.