510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K871884Substantially Equivalent

In the Ear & in the Canal Hearing Aid Face Plate

Hearing Services, Inc., Eden Prairie MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871884 is the FDA 510(k) clearance record for IN THE EAR & IN THE CANAL HEARING AID FACE PLATE, a class I device, cleared for Hearing Services, Inc. on under FDA product code LRB (Face Plate Hearing Aid). FDA records list 3 510(k) clearances for Hearing Services, Inc., from to . As of , FDA records show no recalls naming K871884.

Clearance record

Decision date
Received
(167 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
Hearing Services, Inc. 7480 Washington Ave. S, Eden Prairie MN
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