Cleared Traditional

K832129 - HEARING AID G3H & G3T

K832129 is the FDA 510(k) clearance for HEARING AID G3H & G3T by Widex Hearing Aid Co., Inc.. It is a Class 1 Ear, Nose, Throat device (product code ESD) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K832129 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
25d
Days
Class 1
Risk

K832129 is an FDA 510(k) clearance for the HEARING AID G3H & G3T. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 25 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 Widex Hearing Aid Co., Inc. devices

Submission Details

510(k) Number K832129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1983
Decision Date July 26, 1983
Days to Decision 25 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
64d faster than avg
Panel avg: 89d · This submission: 25d
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 612
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K832129.
RIONET HEARING AID HB-345
K833134 · Rion Acoustic Instruments, Inc. · Nov 1983
WIDEX HEARING AID MODEL L1
K832376 · Widex Hearing Aid Co., Inc. · Sep 1983
HEARING AID UNITRON #UE8-D
K831883 · Unitron Industries, Inc. · Aug 1983
PERSONAL AMPLIFIER MODULE
K830790 · Electone, Inc. · Jul 1983
RIONET HEARING AID -AND/OR RION
K831721 · Rion Acoustic Instruments, Inc. · Jul 1983
WIDEX HEARING AID #G2H & G2T
K830465 · Widex Hearing Aid Co., Inc. · May 1983