Jacoti Hearing Center Status

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.  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.  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.  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.  Jacoti Hearing Center is a Class II FDA listed Medical Device, classified under product code EWO in the U.  Jacoti Hearing Center is a Class II FDA listed Medical Device, classified under product code EWO in the U. S.  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.  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 uses the DuoTone® method for measuring your hearing loss in both ears and allows you to track your hearing health over time.  Jacoti Hearing Center requires you to register with a valid email account on earCloud® ( ), which allows you to share your audio profile across devices.  Jacoti Hearing Center is tested and approved in compliance with the most rigorous medical standards.  Jacoti Hearing Center is a software-based hearing assessment tool that can evaluate your hearing in about 5 minutes.  Please go to to download or request a printed version of the Jacoti Hearing Center Instructions For Use.  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 application allows to store the test results in Apple Health App where other applications can fetch this data from.