K251208 is an FDA 510(k) clearance for the Tuned Self-Fitting Mobile App. This device is classified as 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 FDA review panel. Regulated under 21 CFR 874.3335. 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..
| 510(k) Number | K251208 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| 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. |