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The CST system is a CD with software that enables a qualified healthcare professional to identify, with the patient's verbal input, the sounds that most closely match the patient's tinnitus. The device is indicated to mask and intermittently mask tinnitus as part of a tinnitus management program. The target population for the device is adults (18 years and over) who present with timitus, that may or may not be accompanied with hearing loss at the higher frequencies, and who are participating in a tinnitus management program.

The Tinnitus Otosound Products LLC (TOP-LLC), Customized Sound Therapy (CST), falls under devices described in 21 CFR 874.3400 Class II, product code KLW. The device is a CD comprised of software with two components: a graphic user interface and cmusic program. The software can be used on a notebook or desktop computer with at least Windows XP (SP2) having at least a 1.2 GHz Pentium III CPU (or equivalent), 256 MB of RAM, 1 GB of free disk space, a CD drive, and an available USB port. The Customized Sound Therapy software produces, and transfers sounds to a sound wave file. This sound file can be stored on any commercially available computer hard drive or portable audio device (PAD) like an iPod.