510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810379Substantially Equivalent

Earette Hearing Aid Sears #8054

Oticon, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810379 is the FDA 510(k) clearance record for EARETTE HEARING AID SEARS #8054, a class I device, cleared for Oticon Corp. on under FDA product code FSD (Binder, Abdominal). FDA records list 68 510(k) clearances for Oticon Corp., from to . As of , FDA records show no recalls naming K810379.

Clearance record

Decision date
Received
(19 days to decision)
Product code
FSD Binder, Abdominal
Regulation
21 CFR 880.5160
Device class
Class I
Review panel
General Hospital
Applicant
Oticon Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FSD

Trailing 12 months

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

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