Cleared Traditional

K915398 - TDR-5 BINAURAL HEARINGAID/WIRELES FM RE...

K915398 is the FDA 510(k) clearance for TDR-5 BINAURAL HEARINGAID/WIRELES FM RE... by Telex Communications, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EPF) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K915398 · Telex Communications, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
49d
Days
Class 2
Risk

K915398 is an FDA 510(k) clearance for the TDR-5 BINAURAL HEARINGAID/WIRELES FM RECEIVER. Classified as Hearing Aid, Group And Auditory Trainer (product code EPF), Class II - Special Controls.

Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 49 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 Telex Communications, Inc. devices

Submission Details

510(k) Number K915398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date January 17, 1992
Days to Decision 49 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
40d faster than avg
Panel avg: 89d · This submission: 49d
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 K915398.
TDR-4 MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915383 · Telex Communications, Inc. · Jan 1992
TDR-4S MONAURAL HEARING AID/WIRELESS FM RECEIVER
K915384 · Telex Communications, Inc. · Jan 1992
TDR-7 BINAURAL HEARING AID/WIRELESS FM RECIEVER
K915397 · 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
GROUP AUDITORY TRAINER,FM RECEIVER
K912356 · Phonic Ear, Inc. · Aug 1991