Cleared Traditional

K893431 - AUDITORY TRAINER PE150R FM RECEIVER

K893431 is the FDA 510(k) clearance for AUDITORY TRAINER PE150R FM RECEIVER 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 111-day FDA review.

K893431 · Phonic Ear, Inc. · Ear, Nose, Throat device
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Aug 1989
Decision
111d
Days
Class 2
Risk

K893431 is an FDA 510(k) clearance for the AUDITORY TRAINER PE150R 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 21, 1989 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Phonic Ear, Inc. devices

Submission Details

510(k) Number K893431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date August 21, 1989
Days to Decision 111 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 89d · This submission: 111d
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 K893431.
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
GROUP AUDITORY TRAINER,FM RECEIVER
K912356 · Phonic Ear, Inc. · Aug 1991
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
PHONIC EAR, MODEL PE475R
K862773 · Phonic Ear, Inc. · Oct 1986