Jacoti Hearing Center 1.6.1

Jacoti bvba – Freeware – iOS
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Jacoti Hearing Center is a software-based hearing assessment tool designed to evaluate your hearing in a quick 5-minute session. It is a Class II FDA listed Medical Device, classified under product code EWO in the U.S., and complies with CE requirements for medical devices (CE 2797) in Europe.

Using the DuoTone® method to measure hearing loss in both ears, Jacoti Hearing Center enables users to monitor their hearing health over time. Currently calibrated for Apple EarPods and Apple AirPods, it is recommended for use in relatively silent environments.

Adhering to stringent medical standards, Jacoti Hearing Center ensures safe and efficient application usage. It allows individuals to conduct self-evaluations of their hearing capabilities in real-life settings without professional assistance.

The application's output aligns with pure tone audiometry tests and complies with the IEC 60645-1 standard audiogram format. To utilize Jacoti Hearing Center, users need to register with a valid email account on earCloud® for data sharing across devices.

Upon downloading the app, users must agree to Jacoti's Privacy Policy available at <a href="https://link.jacoti.com/privacy">this link</a>. Additionally, users can access the Jacoti Hearing Center Instructions For Use by visiting <a href="https://link.jacoti.com/hearing-center-support">this link</a>.

The application integrates with the Apple Health App for storing test results, allowing other apps to access this data. It is compatible with specific iPhone models listed as follows: 11, 11 Pro, 11 Pro Max, SE 2nd Gen, 12, 12 Pro, 12 Pro Max, 12 Mini, 13, 13 Pro, 13 Pro Max, and 13 Mini.

UDI (01)05407004250021(10)010601

<h3>For the USA</h3>
In the United States of America, Jacoti Hearing Center serves as a Class II FDA listed Medical Device under product code EWO. It facilitates hearing assessments through controlled acoustic signals for both consumer and professional use.

In a consumer context, Jacoti Hearing Center acts as a screening tool for informational purposes only when utilized without professional guidance in real-world scenarios. The assessment is restricted to individuals aged 18 years and older. Under the supervision of an audiologist or hearing expert, it also functions as a diagnostic audiometer for fitting and testing hearing aids.

<h3>USA Disclaimer</h3>
Jacoti Hearing Center is a comprehensive clinical audiometer conforming to EN 60645-1 and ANSI S3.6 standards when used under professional guidance by trained healthcare providers like audiologists or hearing professionals.
<ul>
<li>When self-administered by consumers, it serves as an informational screening test and not a diagnostic evaluation. For a thorough assessment of your hearing health, it is advised to consult a licensed hearing care professional.</li>
</ul>

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1.6.1

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