Cleared Traditional

Tinnitogram Signal Generator

K221168 · Goldenear Company, Inc. · Ear, Nose, Throat

Feb 2023

Decision

285d

Days

Class 2

Risk

About This 510(k) Submission

K221168 is an FDA 510(k) clearance for the Tinnitogram Signal Generator, a Masker, Tinnitus (Class II — Special Controls, product code KLW), submitted by Goldenear Company, Inc. (Santa Clarita, US). The FDA issued a Cleared decision on February 1, 2023, 285 days after receiving the submission on April 22, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3400.

Submission Details

510(k) Number	K221168 FDA.gov
FDA Decision	Cleared 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