Tinnitus Sound Generator Module— 510(k) K181586

Substantially Equivalent

GN Hearing A/S

FDA 510(k) clearance K181586 for Tinnitus Sound Generator Module, Substantially Equivalent on 2018-07-13. Applicant: GN Hearing A/S. Device class: 2.

Clearance details

Applicant: GN Hearing A/S
Product code: Code KLW
Device class: Class 2
Regulation: 21 CFR 874.3400
Advisory panel: Ear, Nose, Throat
Date received: 2018-06-15
Decision date: 2018-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Ballerup, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLW

K260413 — Levo Gen 2 Tinnitus Therapy System2026-08-13
K260614 — Tinnitus Therapy2026-06-10
K233435 — Peace N Quiet (0.7.0)2024-02-27
K223694 — Tinearity G1 (6103); Tinearity G1 Adapters x3 (6042)2023-06-30
K221168 — Tinnitogram Signal Generator2023-02-01

More clearances from GN Hearing A/S

K254108 — Jabra Enhance Select Self-fit (Jabra Enhance Select 550)2026-06-25
K213424 — Jabra Enhance Plus2022-01-19
K193303 — Tinnitus Sound Generator Module2020-02-20
K180495 — Tinnitus Sound Generator Module2018-11-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.