Tuned Hearing App

Sofern nicht anders angegeben, gelten die Funktionen für iPhone und Android.

1. Evidence: III. Registration; rules for user conduct and use of the App and Service.
2. The app and service are currently free, but Tuned reserves the right to start charging at any time; use also requires compatible hearing aids bought separately.
3. Evidence: 510(k) Summary, 6. Intended Use/Indications for Use.
4. Evidence: I. Information We Collect.
5. Evidence: II. How We Use and Share Information — Google Analytics.
6. Applies to chatbot conversations and support-case history, which Tuned collects; does not describe hearing-aid audio. Evidence: I. Information We Collect.
7. Fine-tuning of the connected hearing aids' amplification in low/mid/high frequency bands; requires compatible Tuned-supported hearing aids (510(k) names Intrisound Tuned Lumen 155 and NoviOne). Evidence: 510(k) Summary, 5. Device Description.
8. Compatible hearing aids supported by Tuned. Professional video support requires a participating provider; this does not establish remote fitting.
9. Requires compatible hearing aids paired over Bluetooth; documented here for the JVC EH-Z1500.
10. Compatible wireless air-conduction hearing aids named in the FDA 510(k) summary; other Tuned-supported models may exist. Evidence: 510(k) Summary, 5. Device Description.
11. JVC EH-Z1500 OTC hearing aids; the manual says the app is required to pair and set them up.
12. Self-fitting (in-app hearing test and NAL-NL2 based configuration) plus volume/program control on compatible hearing aids such as Lumen 155 and NoviOne; self-fitting by the user, not by a professional. Evidence: 510(k) Summary, 5. Device Description.