Cleared Abbreviated

K132965 - SOLACE SOUND GENERATORS (FDA 510(k) Clearance)

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

K132965 · Amplisound Hearing Products & Services · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
186d
Days
Class 2
Risk

K132965 is an FDA 510(k) clearance for the SOLACE SOUND GENERATORS. Classified as Masker, Tinnitus (product code KLW), Class II - Special Controls.

Submitted by Amplisound Hearing Products & Services (Danielson, US). The FDA issued a Cleared decision on March 25, 2014 after a review of 186 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 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 Amplisound Hearing Products & Services devices

Submission Details

510(k) Number K132965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2013
Decision Date March 25, 2014
Days to Decision 186 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
97d slower than avg
Panel avg: 89d · This submission: 186d
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 K132965.
Peace N Quiet (0.7.0)
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Tinearity G1 (6103)
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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