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510(k) Data Aggregation
K Number
K112752Device Name
TINNITUS THERAPY SYSTEM ANM T30 CR
Manufacturer
Date Cleared
2011-12-16
(86 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
ANM ADAPTIVE NEUROMODULATION GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system.
The ANM T30 CR® Stimulator is a patient device for home use.
The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.
Device Description
The ANM T30 CR® is a computer-controlled system for tinnitus therapy is provided to the patient by individualized, ambient acoustic tones. The system consists of four components:
ANM T30 CR® Programmer (computer) including the tinnitus analysis software ANM T30 CR® SW: The ANM T30 CR® Software is used to measure the tinnitus, adjust the individual therapeutic stimulation signals and program the patient device (ANM T30 CR® Stimulator).
ANM T30 CR® Patient Console: The ANM T30 CR® Patient Console is connected to the ANM T30 CR® Programmer and is used by the patient to adjust the parameters specific to his/her tinnitus (frequency and loudness) during tinnitus measurement and stimulation signal adjustment.
ANM T30 CR® Stimulator (patient device): The stimulator is used by the patient for the application of the therapeutic stimulation signal. It has a rechargeable battery for the energy supply and electronic components to generate the stimulation signal.
ANM T30 CR® Earphones: The ANM T30 CR® Earphones are to be connected either to the ANMT30 CR® Patient Console to measure the tinnitus and adjust the stimulation signal or to the ANM T30 CR® Stimulator to apply the stimulation signal.
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