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510(k) Data Aggregation
K Number
K061459Device Name
TRANQUIL TRI-BTE
Manufacturer
GENERAL HEARING INSTRUMENTS, INC.
Date Cleared
2006-06-30
(35 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
GENERAL HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tranquil TRI-BTE is for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
Device Description
Not Found
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K Number
K974751Device Name
TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC
Manufacturer
GENERAL HEARING INSTRUMENTS, INC.
Date Cleared
1998-03-06
(77 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
GENERAL HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are not an issue.
A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss when the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue.
A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are a major issue.
Device Description
Tranquil TRI-OE: I-T-E hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 312 battery.
Tranquel TRI-COE: I-T-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.
Tranquel TRI-CIC: C-I-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.
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K Number
K971399Device Name
AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CIC
Manufacturer
GENERAL HEARING INSTRUMENTS, INC.
Date Cleared
1997-06-13
(59 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
GENERAL HEARING INSTRUMENTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mild to severe conductive, mixed or sensoryneural hearing loss
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are of some concern
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern, but the ear can not accommodate a complete in the canal style
Mild to moderate conductive, mixed or sensoryneural hearing loss when cosmetics are of major concern.
Mild to severe conductive, mixed or sensoryneural hearing loss when a more cosmetic AE is desired.
Mild to severe conductive, mixed or sensoryneural hearing loss when cosmetics are a major concern but the ear prevents use of a CIC or MM.
Normal low and middle frequency hearing with a sloping mild to moderate high frequency sensory neural or mixed loss.
Device Description
To amplify and transmit sound to the ear.
DSD K-amp or Intrigue programmable circuitry
Assembled from standard components that are widely used by other hearing aid manufacturers.
"Technical specifications comply with S3.2-1987 ANSI Standards"
Frequency response dictated by individual audiogram
Volume control similar to other devices.
Standard size 13 battery
Standard size 312 battery
Standard size 10A battery
Standard size 10a or 5a battery
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