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510(k) Data Aggregation
K Number
K982451Device Name
TTCGHI-T AND TTCTN3-T-T
Manufacturer
Date Cleared
1999-05-07
(296 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
TINNITUS TREATMENT CENTERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The noise and the relaxation/cognitive tapes, when used in a comprehensive tinnitus adaptation therapy program, are indicated for the temporary relief of tinnitus symptoms and the promotion of relaxation during the tinnitus adaptation process.
Device Description
The noise used in the Tinnitus Adaptation Therapy program is a broad-band noise that has been recorded onto a standard audio cassette and can be played on any commercially available audio cassette player and listened to through any commercially available headphones or speakers.
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K Number
K982432Device Name
PILLOW MASKER, C2007M, C2008M,CE2000, WONDER EAR, MINI WONDER EAR, PT-2SM, PT-3SM, PT-3LFM, PT-3HFM, PT3CM, PT5-SM, PT5-
Manufacturer
Date Cleared
1999-01-25
(196 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
TINNITUS TREATMENT CENTERS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The tinnitus masking noise is used as an adjunct to assist individuals with tinnitus to learn to refocus their attention away from their timitus and towards an alternate sound such as the recorded noise. The level of the noise should be adjusted by the individual to a level below their tinnitus so that both the noise and the tinnitus can be heard simultaneously. However, if the individual wishes to completely "mask-out" the tinnitus, then the noise could be adjusted so that the noise is louder than the tinnitus.
These combination timilas maskers and hearing aid devices can be used by people who not colly have thatias, but who also have a hearing impairment. Those devices will be sold in compliance with CFR 801.420 and will include additional labeling for hearing aids.
These same tinnitus masking devices can also be used by individuals who desire to mask out ambient environmental noise (e.g. office noise, outside noise, snoring, and other oborusive noises).
Device Description
The tinnitus maskers are broad-band white noise signal generators. They are housed in a variety of hearing aid-type shell configurations that can then be worn either in-the-ear or behind-the-ear. In some instances, canal size permitting, the tinnitus masker circuit can also fit inside a hearing aid shell allowing the patient to benefit from amplified hearing while masking their tinnitus.
The noise is a broad-band white noise signal that can be housed in a variety of In-The-Bar or Behind-The-Bar thessing aid type) shouls.
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