510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897023Substantially Equivalent

Oversight Program for in-Office Assembly, Hrng Aid

Audina Hearing Instrument, Inc, Longwood FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897023 is the FDA 510(k) clearance record for OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID, a class I device, cleared for Audina Hearing Instrument on under FDA product code LRB (Face Plate Hearing Aid). FDA records list 8 510(k) clearances for Audina Hearing Instrument, from to . As of , FDA records show no recalls naming K897023.

Clearance record

Decision date
Received
(87 days to decision)
Product code
LRB Face Plate Hearing Aid
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Audina Hearing Instrument 150 Wildmere St., Longwood FL
Third party review
No

Clearances, product code LRB

Trailing 12 months

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

FDA records show no clearances under product code LRB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRB, 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