Tinnitus Sound Generator Module
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180495 FDA 510(k)
- FDA Product Code
- KLW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3400 FDA 510(k)
- Regulation Number
- 874.3400 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Tinnitus Sound Generator Module is a software module embedded in digital hearing instruments that generates sounds for temporary tinnitus relief. It is classified as a Masker, Tinnitus device under FDA regulation number 874.3400 and is intended for use in the Ear, Nose, Throat medical specialty.
The device must be fitted by a hearing professional participating in a Tinnitus Management Program. After initial fitting by a healthcare professional, end-users may adjust settings via a mobile app (Smart3D). It is supplied as part of a hearing instrument system and has received FDA 510(k) clearance under K180495 with product code KLW.
Frequently asked questions
What is the Tinnitus Sound Generator Module used for?
The Tinnitus Sound Generator Module is a software module embedded in digital hearing instruments that generates sounds for temporary tinnitus relief. It is intended for use in the Ear, Nose, Throat medical specialty and must be fitted by a hearing professional participating in a Tinnitus Management Program.
How is the Tinnitus Sound Generator Module supplied and adjusted?
The device is supplied as part of a hearing instrument system and is not sold separately. After initial fitting by a healthcare professional, end-users may adjust settings via a mobile app (Smart3D). It requires professional fitting before user adjustments can be made.
Is the Tinnitus Sound Generator Module a single-use or reusable device?
The Tinnitus Sound Generator Module is a software component embedded in digital hearing instruments, making it reusable for the lifetime of the host device. It is not a physical consumable and does not require replacement based on use cycles.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tinnitus Sound Generator Module (K180495) — FDA 510 (k) | Innolitics, Tinnitus Sound Generator Module (K181586) — FDA 510 (k) | Innolitics, Tinnitus Sound Generator Module 510 (k) K181586 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180495 | Class II | Active |
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Manufacturer
- Manufacturer
- Gn Hearing A/S
Sources (1)
- FDA 510(k) K180495 24 fields · synced Sep 28, 2026