Cleared Traditional

K900846 - MODEL 366 HEARING AID

K900846 is the FDA 510(k) clearance for MODEL 366 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 90-day FDA review.

K900846 · Telex Communications, Inc. · Ear, Nose, Throat device
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May 1990
Decision
90d
Days
Class 1
Risk

K900846 is an FDA 510(k) clearance for the MODEL 366 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 23, 1990 after a review of 90 days - within the typical 510(k) review window.

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: 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 Telex Communications, Inc. devices

Submission Details

510(k) Number K900846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1990
Decision Date May 23, 1990
Days to Decision 90 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
1d slower than avg
Panel avg: 89d · This submission: 90d
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 K900846.
BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC
K900829 · Phonak, Inc. · May 1990
BTE SUPER-FRONT PPCL4, SUPER-FRONT PPC4
K900830 · Phonak, Inc. · May 1990
BTE PICO SCD, PICO SC
K900831 · Phonak, Inc. · May 1990
WIDEX HEARING AID MODEL THE DISCOVERY
K901642 · Widex Hearing Aid Co., Inc. · May 1990
SIEMENS MODEL 284 PP-L
K893573 · Siemens Hearing Instruments, Inc. · May 1990
SIEMENS MODEL 284 PP-AGC
K893574 · Siemens Hearing Instruments, Inc. · May 1990