Cleared Traditional

K922066 - TELEX MODEL 28A ITE CUSTOM HEARING AID

K922066 is the FDA 510(k) clearance for TELEX MODEL 28A ITE CUSTOM HEARING AID 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 14-day FDA review.

K922066 · Telex Communications, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
14d
Days
Class 1
Risk

K922066 is an FDA 510(k) clearance for the TELEX MODEL 28A ITE CUSTOM HEARING AID. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 18, 1992 after a review of 14 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 K922066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date May 18, 1992
Days to Decision 14 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
75d faster than avg
Panel avg: 89d · This submission: 14d
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 K922066.
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OTOSONIC ACS-IC
K922224 · Beltone Electronics Corp. · May 1992
TELEX MODEL M29 ITE CUSTOM HEARING AID
K922065 · Telex Communications, Inc. · May 1992
LIFESOUND ITE (LSI-I)W/ TRITON 3004I PROGRAMMABLE
K921656 · Siemens Hearing Instruments, Inc. · May 1992
RIONET HEARING AID HB-52S
K921829 · Authorized Hearing Systems, Inc. · Apr 1992
RIONET HEARING AID HB-52T
K921830 · Authorized Hearing Systems, Inc. · Apr 1992