# K221125: SilentCloud

- Pathway: 510(k) (Traditional)
- Applicant: Aureliym GmbH
- Decided: Jan 4, 2023 after 261 days
- Product code: KLW (Masker, Tinnitus)
- Device class: 2
- Regulation: 21 CFR 874.3400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K260413: Levo Gen 2 Tinnitus Therapy System (2026), 0 descendants of its own

## Indications for use
The SilentCloud in combination with a Tinnitus Management Program is a therapeutic software tool for the treatment of chronic subjective tinnitus for home use. The target population for the Universal Tinnitus Management System are adult tinnitus patients over 18 years. The SilentCloud is intended to provide relief from the disturbance of chronic subjective tinnitus while using the device. The SlientCloud is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.

Source page: https://510kreport.com/device/K221125
Methodology: https://510kreport.com/methodology