Cleared Traditional

K221168 - Tinnitogram Signal Generator

K221168 is an FDA 510(k) clearance for Tinnitogram Signal Generator, manufactured by Goldenear Company, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K221168 · Goldenear Company, Inc. · Ear, Nose, Throat device
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Feb 2023
Decision
285d
Days
Class 2
Risk

K221168 is an FDA 510(k) clearance for the Tinnitogram Signal Generator. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Goldenear Company, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on February 1, 2023 after a review of 285 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3400 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Goldenear Company, Inc. devices

FDA 510(k) Submission Details - K221168

510(k) Number K221168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2022
Decision Date February 01, 2023
Days to Decision 285 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 89d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLW Device Classification - Class 2, Special Controls

Product Code KLW Masker, Tinnitus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KLW Masker, Tinnitus

All 22
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K221168.
Peace N Quiet (0.7.0)
K233435 · Pnq Health · Feb 2024
Tinearity G1 (6103)
K223694 · Duearity AB · Jun 2023
SilentCloud
K221125 · Aureliym GmbH · Jan 2023
Multiflex Tinnitus Technology
K201370 · Starkey Laboratories, Inc. · Jun 2020
Tinnitus Sound Generator Module
K193303 · GN Hearing A/S · Feb 2020
Tinnitus Sound Generator Module
K180495 · GN Hearing A/S · Nov 2018