Cleared Traditional

Tuned Self-Fitting Mobile App

K251208 · Tuned , Ltd. · Ear, Nose, Throat
Sep 2025
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K251208 is an FDA 510(k) clearance for the Tuned Self-Fitting Mobile App, a Air-conduction Hearing Aid Software (Class II — Special Controls, product code SCR), submitted by Tuned , Ltd. (Gan Yoshiya, IL). The FDA issued a Cleared decision on September 26, 2025, 161 days after receiving the submission on April 18, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3335.

Submission Details

510(k) Number K251208 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2025
Decision Date September 26, 2025
Days to Decision 161 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code SCR — Air-conduction Hearing Aid Software
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3335
Definition 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 This Classification Are Also Subject To The Requirements In § 800.30 Or § 801.422 Of This Chapter, As Applicable. This Classification Does Not Include Software That Is Used With Hardware As Part Of A Hearing-aid Device System Classified In Other Regulations, E.g., § 874.3300, § 874.3305, Or § 874.3325.