Jacoti Hearing Center

Jacoti Hearing Center is a software-based hearing assessment tool that can evaluate your hearing in about 5 minutes.

Jacoti Hearing Center is a Class II FDA listed Medical Device, classified under product code EWO in the U.S and complies with the CE requirements for medical devices (CE 2797) in Europe.

Jacoti Hearing Center uses the DuoTone® method for measuring your hearing loss in both ears and allows you to track your hearing health over time. It is currently calibrated for the Apple EarPods and Apple AirPods and can be safely used in relatively silent environments.

Jacoti Hearing Center is tested and approved in compliance with the most rigorous medical standards. This guarantees you safe and efficient use of the application.

The intended use of Jacoti Hearing Center is for individuals to perform by means of acoustic signals with controlled intensity hearing self-evaluations in real-life environments without the assistance of a hearing expert. The output provided by Jacoti Hearing Center is consistent with that of a pure tone audiometry test and compliant with the IEC 60645-1 standard audiogram format.

Jacoti Hearing Center requires you to register with a valid email account on earCloud® (https://earcloud.net/), which allows you to share your audio profile across devices.

Note that by downloading this app, you are required to agree to Jacoti's Privacy Policy, which you can find at: https://link.jacoti.com/privacy.

Please go to https://link.jacoti.com/hearing-center-support to download or request a printed version of the Jacoti Hearing Center Instructions For Use.

The application allows to store the test results in Apple Health App where other applications can fetch this data from.

The application requires the use of one of the following iPhone models: 11 / 11 Pro / 11 Pro Max / SE 2nd Gen / 12 / 12 Pro / 12 Pro Max / 12 Mini / 13 / 13 Pro / 13 Pro Max / 13 Mini

UDI (01)05407004250021(10)010601



FOR THE USA

Jacoti Hearing Center is a Class II FDA listed Medical Device, classified under product code EWO in the U.S.


In the United States of America, the intended use of Jacoti Hearing Center is limited to performing hearing assessments by means of acoustic signals with controlled intensity. It is designed for both consumer and professional use.

When used by consumers in real-life environments without the assistance of a hearing expert, Jacoti Hearing Center is intended as a screening device for informational purposes. Limit its usage to adults, 18 years of age or older. When used under the guidance of an audiologist or a hearing professional, Jacoti Hearing Center is intended to be used as a hearing fitting and hearing diagnostic audiometer.

USA DISCLAIMER

Jacoti Hearing Center is a full-function professional clinical audiometer that partially conforms to EN 60645-1 for audiometers and ANSI S3.6 for Type 4 audiometers.

It is only intended for official diagnosis when administered by a trained health care professional such as an audiologist or hearing professional.

When self-administered, this hearing test is intended for use as a screening device for informational purposes only. The results are not intended as a diagnostic evaluation. For a complete test and evaluation of your hearing, you should visit a qualified and licensed hearing care professional.