Cleared Traditional

K912356 - GROUP AUDITORY TRAINER

K912356 is the FDA 510(k) clearance for GROUP AUDITORY TRAINER by Phonic Ear, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EPF) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K912356 · Phonic Ear, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
79d
Days
Class 2
Risk

K912356 is an FDA 510(k) clearance for the GROUP AUDITORY TRAINER,FM RECEIVER. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Phonic Ear, Inc. (Mill Valley, US). The FDA issued a Cleared decision on August 15, 1991 after a review of 79 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

Submission Details

510(k) Number K912356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1991
Decision Date August 15, 1991
Days to Decision 79 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
10d faster than avg
Panel avg: 89d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (EPF) and FDA review panel - the closest regulatory comparables to K912356.
TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER
K915398 · Telex Communications, Inc. · Jan 1992
TELEX TDR-4AA MONAURAL HEAR AID/WIRELESS FM REC
K913494 · Telex Communications, Inc. · Nov 1991
TELEX TDR-7AA BINAURAL HEAR AID/WIRELESS FM REC
K913495 · Telex Communications, Inc. · Nov 1991
AUDITORY TRAINER PE150R FM RECEIVER
K893431 · Phonic Ear, Inc. · Aug 1989
PE100R FM RECEIVER USED W/PE100T FM TRANSMITTER
K882409 · Phonic Ear, Inc. · Jul 1988
PE485R FM RECEIVER USED W/PE481FST FM TRANSMITTER
K881099 · Phonic Ear, Inc. · Jun 1988