Cleared Traditional

K791601 - MODEL 336A HEARING AIDS

K791601 is the FDA 510(k) clearance for MODEL 336A HEARING AIDS by Telex Communications, Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K791601 · Telex Communications, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1979
Decision
45d
Days
Class 1
Risk

K791601 is an FDA 510(k) clearance for the MODEL 336A HEARING AIDS. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Telex Communications, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1979 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - 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 K791601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1979
Decision Date September 28, 1979
Days to Decision 45 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
44d faster than avg
Panel avg: 89d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ESD Hearing Aid, Air-conduction, Prescription

All 739
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K791601.
DAHLBERG HEARING AID MODEL GC
K791310 · Dahlberg Electronics, Inc. · Sep 1979
MODEL 33DA HEARING AIDS
K791599 · Telex Communications, Inc. · Sep 1979
MODEL 33A HEARING AIDS
K791600 · Telex Communications, Inc. · Sep 1979
DAHLBERG HEARING AID MODEL UN
K791311 · Dahlberg Electronics, Inc. · Sep 1979
MODEL 344
K791506 · Telex Communications, Inc. · Sep 1979
EARETTE HEARING AID
K791356 · Oticon Corp. · Sep 1979