Cleared Traditional

K911726 - PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION

K911726 is an FDA 510(k) clearance for PROGRAMMABLE AUDITORY COMPARATOR, manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KHL cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K911726 · Bausch & Lomb, Inc. · Ear, Nose, Throat device
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Oct 1991
Decision
195d
Days
Class 2
Risk

K911726 is an FDA 510(k) clearance for the PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION. Classified as Hearing Aid, Master (product code KHL), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Tucker, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 195 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3330 - 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.

FDA 510(k) Submission Details - K911726

510(k) Number K911726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1991
Decision Date October 23, 1991
Days to Decision 195 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
105d slower than avg
Panel avg: 90d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KHL Device Classification - Class 2, Special Controls

Product Code KHL Hearing Aid, Master
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KHL Hearing Aid, Master

Devices cleared under the same product code (KHL) and FDA review panel - the closest regulatory comparables to K911726.
LORI HEARING AID SIMULATOR
K964080 · Lori Medical Laboratories, Inc. · Jan 1997
RESOUND DEMO. BEHIND-THE-EAR HRNG., MODEL DEMO BTE
K894019 · Resound Corp. · Sep 1989
VOROBA PROGRAMMABLE AUDITORY COMPARATOR
K860171 · Voroba Technologies Assoc. · May 1986
CRAIGWELL MASTER HEARING AID MHA
K854126 · Craigwell Electronics, Ltd. · Jan 1986
MODEL FS1
K790481 · Starkey Laboratories, Inc. · Apr 1979
K911726 · PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION
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