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510(k) Data Aggregation
K Number
K030791Device Name
ANMP (ACOUSTIC NEURO MODULATION PROTOCOL)
Manufacturer
TINNITECH LTD
Date Cleared
2003-04-17
(36 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
TINNITECH LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TinniTech ANMP System comprises two (2) mini compact disks and a portable, stereo, MP3 mini compact disc player with earphones. The discs have been prerecorded with selected relaxation music and other sounds spectrally adjusted to suit the particular patient's spectral hearing thresholds as shown by their audiogram. The sounds on the discs are reproduced by the mini compact disc player and delivered to the ears by the earphones supplied with the player. The device is indicated for adult (18 years and over) tinnitus sufferers who may or may not suffer higher frequencies hearing loss and are participating in a tinnitus management program.
The TinniTech ANMP System is for home use under the direction of an appropriately qualified healthcare professional such as an otolaryngologist, an audiologist, or a licensed hearing aid dealer.
Patients should receive a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) to rule out medically or surqically treatable diseases for which tinnitus is a symptom before proceeding with non-medical tinnitus management.
The Tinnitech ANMP System may be used to completely mask and intermittently mask tinnitus.
Device Description
The TinniTech ANMP system consists of:
One CD pre-recorded in the MP3 format with selected relaxation music and superimposed low amplitude, wide spectrum noise that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss. This CD is intended for the complete masking of tinnitus.
One CD pre-recorded in the MP3 format with selected relaxation music that is spectrally adapted to compensate for the individual patient's higher frequencies hearing loss however this CD has been recorded such that the dynamic characteristics of the sound allow the tinnitus to intermittently break through during the quieter passages of the recorded music.
A commercially available, battery powered, stereo, MP3 mini compact disc player with earphones with a performance specification that TinniTech has tested and shown to be suitable for the delivery of the ANMP treatment sounds or waveforms. At this time Tinnitech will supply the Phillips eXpanium 401™ MP3 mini compact disc player. Other suitable players will be offered as TinniTech tests and approves them for the ANMP System.
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