Cleared Abbreviated

K123450 - PHONAK TINNITUS BALANCE (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K123450 · Phonak, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
94d
Days
Class 2
Risk

K123450 is an FDA 510(k) clearance for the PHONAK TINNITUS BALANCE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Phonak, LLC (Warrenville, US). The FDA issued a Cleared decision on February 11, 2013 after a review of 94 days - within the typical 510(k) review window.

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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Phonak, LLC devices

Submission Details

510(k) Number K123450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2012
Decision Date February 11, 2013
Days to Decision 94 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 89d · This submission: 94d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 75
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K123450.
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SilentCloud
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Multiflex Tinnitus Technology
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K193303 · GN Hearing A/S · Feb 2020