510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971807Substantially Equivalent

In the Ear, in the Canal, Completely in the Canal

Hear-Right, Inc., Oklahoma City OK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971807 is the FDA 510(k) clearance record for IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL, a class I device, cleared for Hear-Right, Inc. 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 Hear-Right, Inc. As of , FDA records show no recalls naming K971807.

Clearance record

Decision date
Received
(84 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
Hear-Right, Inc. 2606 Villa Prom, Suite 74, Oklahoma City OK
510(k) summary
Statement
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