Cleared Traditional

K970687 - WILLIAMS SOUND

K970687 is an FDA 510(k) clearance for WILLIAMS SOUND, manufactured by Williams Sound, LLC. The device is a Class 2 Ear, Nose, Throat device with product code EPF cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K970687 · Williams Sound, LLC · Ear, Nose, Throat device
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May 1997
Decision
67d
Days
Class 2
Risk

K970687 is an FDA 510(k) clearance for the WILLIAMS SOUND, PERSONAL FM, HEARING HELPER. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Williams Sound, LLC (Eden Prairie, US). The FDA issued a Cleared decision on May 2, 1997 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Williams Sound, LLC devices

FDA 510(k) Submission Details - K970687

510(k) Number K970687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date May 02, 1997
Days to Decision 67 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 89d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EPF Device Classification - Class 2, Special Controls

Product Code EPF Hearing Aid, Group And Auditory Trainer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3320
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 - EPF Hearing Aid, Group And Auditory Trainer

All 21
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K970687.
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
K982683 · Telex Communications, Inc. · Oct 1998
INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT
K974658 · Phonic Ear, Inc. · Feb 1998
FM RECEIVER - AUDITORY TRAINER
K974287 · Phonic Ear, Inc. · Feb 1998
GROUP AUDITORY TRAINER (GROUP AMPLIFICATION SYSTEM)
K950730 · Phonic Ear, Inc. · Jun 1995
PHONAK MICROVOX RESONAL FM SYSTEM
K941768 · Phonak, Inc. · Jun 1994
PHONIC EAR
K940313 · Phonic Ear, Inc. · Mar 1994