Jacoti Hearing Center Pro 12‏+

Jacoti Hearing Center Pro is an audiometer application for iPad that performs clinically valid hearing assessments in a matter of minutes without an audiological booth.

Jacoti Hearing Center Pro 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 (Medical Device Regulation (EU) 2017/745, CE 2797) in Europe.

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

Jacoti Hearing Center Pro is a tool for audiometric evaluation by means of acoustic signals with controlled intensity. It is intended to be used by individuals to perform hearing self-evaluations in a sufficiently quiet environment under the supervision of a test leader. The output provided by Jacoti Hearing Center Pro is consistent with that of a pure tone audiometry test and compliant with the IEC 60645-1 standard audiogram format.

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-pro-support to download or request a printed version of the Jacoti Hearing Center Pro Instructions for Use.

The application requires the use of one of the following iPad model: Mini 6

UDI

(01)05407004250038(10)010201



FOR THE USA

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


In the United Stated of America, the intended use of Jacoti Hearing Center Pro is limited to performing hearing assessments by means of acoustic signals with controlled intensity.

It is suitable for both consumer and professional use. However, it is designed for professional value.

When used by consumers in real-life environments without the assistance of a hearing expert, Jacoti Hearing Center Pro 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 Pro is intended to be used as a hearing fitting and hearing diagnostic audiometer.

USA DISCLAIMER

Jacoti Hearing Center Pro is only intended for official diagnosis when administered by a trained health care professional such as an audiologist or hearing professional. When administered by a qualified test leader, this hearing test is intended for use as a screening device for informational purposes only and the results are not intended as a diagnostic evaluation.