Cleared Abbreviated

K130494 - UNITRON TINNITUS MASKER FEATURE

K130494 is an FDA 510(k) clearance for UNITRON TINNITUS MASKER FEATURE, manufactured by Unitron Hearing. The device is a Class 2 Ear, Nose, Throat device with product code KLW cleared through the Abbreviated 510(k) pathway after a 70-day FDA review.

K130494 · Unitron Hearing · Ear, Nose, Throat device
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May 2013
Decision
70d
Days
Class 2
Risk

K130494 is an FDA 510(k) clearance for the UNITRON TINNITUS MASKER FEATURE. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Unitron Hearing (Plymouth, US). The FDA issued a Cleared decision on May 7, 2013 after a review of 70 days - a notably fast clearance 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 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 Unitron Hearing devices

FDA 510(k) Submission Details - K130494

510(k) Number K130494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2013
Decision Date May 07, 2013
Days to Decision 70 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 90d · This submission: 70d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KLW Masker, Tinnitus

All 60
Devices cleared under the same product code (KLW) and FDA review panel - the closest regulatory comparables to K130494.
WAVE 2G, SOUL
K130937 · Hansaton Akustik GmbH · Jan 2014
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
K130514 · Audifon-USA, Inc. · Nov 2013
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
K130417 · Audifon-USA, Inc. · Sep 2013
PHONAK TINNITUS BALANCE
K123450 · Phonak, LLC · Feb 2013
MULTIFLEX TINNITUS TECHNOLOGY
K122876 · Starkey Laboratories · Oct 2012
TINNITUS THERAPY SYSTEM ANM T30 CR
K112752 · Anm Adaptive Neuromodulation GmbH · Dec 2011

FDA 510(k) Resources - Ear, Nose, Throat

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.