510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K251208Substantially Equivalent

Tuned Self-Fitting Mobile App

Tuned, Ltd., Gan Yoshiya, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K251208 is the FDA 510(k) clearance record for Tuned Self-Fitting Mobile App, a class II device, cleared for Tuned , Ltd. on under FDA product code SCR (Air-Conduction Hearing Aid Software). FDA's definition for product code SCR reads: "Air-conduction hearing aid software is a device that is intended to be used with a compatible wearable hardware platform to compensate for impaired hearing. The software also allows for customization to the user's hearing needs. Devices in...". FDA records list 2 510(k) clearances for Tuned , Ltd., from to . As of , FDA records show no recalls naming K251208.

Clearance record

Decision date
Received
(161 days to decision)
Product code
SCR Air-Conduction Hearing Aid Software
Regulation
21 CFR 874.3335
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Tuned , Ltd. 18 Harimon St., Gan Yoshiya, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SCR

Trailing 12 months
2 clearances under product code SCR in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code SCR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260