510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882005Substantially Equivalent

Harmony Hearing Aid Models Lp, M, Ho, HF, & C

Harmony Hearing Aids, Co., Northfield Center OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882005 is the FDA 510(k) clearance record for HARMONY HEARING AID MODELS LP, M, HO, HF, & C, a class I device, cleared for Harmony Hearing Aids, Co. on under FDA product code ESD (Hearing Aid, Air-Conduction, Prescription). FDA's definition for product code ESD reads: "An air-conduction hearing aid is a wearable sound amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. This is a prescription hearing aid". FDA records list one 510(k) clearance for Harmony Hearing Aids, Co. As of , FDA records show no recalls naming K882005.

Clearance record

Decision date
Received
(60 days to decision)
Product code
ESD Hearing Aid, Air-Conduction, Prescription
Regulation
21 CFR 874.3300
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Harmony Hearing Aids, Co. 9425 Olde Eight Rd., Northfield Center OH
Third party review
No

Clearances, product code ESD

Trailing 12 months

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

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