Cleared Traditional

K943706 - AUDILENS LLK

K943706 is the FDA 510(k) clearance for AUDILENS LLK 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 21-day FDA review.

K943706 · Widex Hearing Aid Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
21d
Days
Class 1
Risk

K943706 is an FDA 510(k) clearance for the AUDILENS LLK. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Widex Hearing Aid Co., Inc. (Long Island City, US). The FDA issued a Cleared decision on August 22, 1994 after a review of 21 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 K943706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1994
Decision Date August 22, 1994
Days to Decision 21 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
68d faster than avg
Panel avg: 89d · This submission: 21d
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 K943706.
SIEMENS MODEL 584 P-2
K934752 · Siemens Hearing Instruments, Inc. · Sep 1994
INFINITY 252
K935019 · Siemens Hearing Instruments, Inc. · Sep 1994
SIEMENS BTE HEARING AIDS
K942857 · Siemens Hearing Instruments, Inc. · Aug 1994
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682 · Starkey Laboratories, Inc. · Aug 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667 · Starkey Laboratories, Inc. · Aug 1994
STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID
K942594 · Starkey Laboratories, Inc. · Jul 1994