Cleared Traditional

K974658 - INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN RECEIVER, INFRARED HEADSET RECEIVER-STEREO, IT

K974658 is an FDA 510(k) clearance for INFRARED GROUP AMPLIFICATION SYSTEM, manufactured by Phonic Ear, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EPF cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K974658 · Phonic Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
72d
Days
Class 2
Risk

K974658 is an FDA 510(k) clearance for the INFRARED GROUP AMPLIFICATION SYSTEM, INFRARED EMITTER, INFRARED BODY WORN REC.... Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Phonic Ear, Inc. (Petaluma, US). The FDA issued a Cleared decision on February 25, 1998 after a review of 72 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 Phonic Ear, Inc. devices

FDA 510(k) Submission Details - K974658

510(k) Number K974658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1997
Decision Date February 25, 1998
Days to Decision 72 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 90d · This submission: 72d
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 24
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K974658.
HYPERSOUND AUDIO SYSTEM (HSS)
K133352 · Hypersound Health, Inc. · Feb 2014
TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSION
K982683 · Telex Communications, Inc. · Oct 1998
FM RECEIVER - AUDITORY TRAINER
K974287 · Phonic Ear, Inc. · Feb 1998
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970665 · Williams Sound, LLC · May 1997
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
K970687 · Williams Sound, LLC · May 1997
HF MEGA EAR
K960567 · Maxi-Aids, Inc. · Oct 1996