510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K911726Substantially Equivalent

Programmable Auditory Comparator, Modification

Bausch & Lomb Incorporated, Tucker GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911726 is the FDA 510(k) clearance record for PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION, a class II device, cleared for Bausch & Lomb, Inc. on under FDA product code KHL (Hearing Aid, Master). FDA records list 131 510(k) clearances for Bausch & Lomb Incorporated, from to . As of , FDA records show no recalls naming K911726.

Clearance record

Decision date
Received
(195 days to decision)
Product code
KHL Hearing Aid, Master
Regulation
21 CFR 874.3330
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bausch & Lomb, Inc. 5243 Royal Woods Pkwy., #100, Tucker GA
Third party review
No

Clearances, product code KHL

Trailing 12 months

FDA records hold no clearances under product code KHL in the trailing twelve months.

FDA records show no clearances under product code KHL in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260