Tuned Self-Fitting Mobile App
by Tuned, Ltd. 510(k)
Active
510(k) K251208
Overview
The Tuned Self-Fitting Mobile App is classified as Air-Conduction Hearing Aid Software under FDA regulation 874.3335. This digital device enables users to adjust hearing parameters independently, providing a self-fitting solution for mild to moderate hearing loss without professional assistance. It operates via a mobile application, leveraging algorithms to customize sound amplification based on user input and feedback. The software is designed for over-the-counter use, targeting individuals seeking accessible hearing support.
The device is supplied as a downloadable mobile application compatible with relevant platforms, requiring no physical hardware beyond standard smartphone components. It is not subject to sterility requirements as it is a software-only solution, but compliance with FDA 510(k) clearance (K251208) ensures its safety and effectiveness for self-fitting hearing aid applications. The app adheres to Class II regulatory standards and is intended for use in consumer settings, with no restrictions on MRI compatibility or reusable components. No additional storage or maintenance specifications are noted beyond standard mobile device storage.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251208 | Date26 Sep 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- SCR
- FDA applicant
- Tuned , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 874.3335
- Advisory Committee
- Ear, Nose, Throat
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tuned, Ltd.
Questions
What is the Tuned Self-Fitting Mobile App used for?
The Tuned Self-Fitting Mobile App is designed for individuals with mild to moderate hearing loss who want to adjust hearing parameters independently. It uses smartphone algorithms to customize sound amplification based on user input, providing a self-fitting solution without requiring professional assistance. This makes it ideal for consumers seeking accessible hearing support in everyday settings.
How is the Tuned Self-Fitting Mobile App supplied?
The app is supplied exclusively as a downloadable mobile application compatible with standard smartphones. No additional hardware is required beyond the user’s existing device. It operates entirely through the mobile platform, eliminating the need for physical components or accessories.
Is sterility required for the Tuned Self-Fitting Mobile App?
No, sterility is not applicable to the Tuned Self-Fitting Mobile App since it is a software-only solution. The app’s safety and effectiveness are ensured through FDA 510(k) clearance (K251208), which confirms its compliance with regulatory standards for self-fitting hearing aid software.
Can the Tuned Self-Fitting Mobile App be reused or is it single-use?
The Tuned Self-Fitting Mobile App is intended for repeated use by individual consumers. Since it operates on a mobile device, there are no reusable components or hardware limitations—users can continue adjusting settings as needed. The app itself is not consumable or disposable.
Are there any special storage or maintenance requirements for the app?
Beyond standard mobile device storage, no additional requirements are specified for the Tuned Self-Fitting Mobile App. Users should ensure their smartphone meets compatibility criteria and maintain regular software updates as recommended by the app developer. No specialized storage conditions (e.g., temperature or humidity) are noted.