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510(k) Data Aggregation
K Number
K060539Device Name
DPOAE20 , ECLIPSE
Manufacturer
INTERACOUSTICS A/S, ASSENS
Date Cleared
2006-05-30
(90 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
INTERACOUSTICS A/S, ASSENS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Interacoustics DPOAE20 system is for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emission tone stimuli.
The presence of Otoacoustic emissions suggests normal outer hair cell function within cochlea, which in turn suggests normal hearing. OAEs are recorded using an OAE orobe which is placed in the ear canal. The OAE response from the ear is recorded and orocessed by the Eclipse and the DPOAE20 software and then displayed on the computer screen for evaluation.
This is of particular interest to Ear, Nose, and Throat doctors, Neurology specialists, Audiologist and other health professionals concerned with measuring auditory functions.
The patient group includes all ages and sexes.
Device Description
Not Found
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K Number
K050496Device Name
REM440
Manufacturer
INTERACOUSTICS A/S, ASSENS
Date Cleared
2005-04-29
(60 days)
Product Code
ETW
Regulation Number
874.3310Why did this record match?
Applicant Name (Manufacturer) :
INTERACOUSTICS A/S, ASSENS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The REM440 system is intended to be used as a system to perform Real Ear Measurement and assist in the adjustment of hearing aids while in use by the patient. It is used by ENT-professionals and in clinics for hearing aid fitting. This device can either be sold individually or together with other Thor Platform modules in the same housing.
Device Description
REM440, (for use with Thor Platform System Products)
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K Number
K030016Device Name
TEOAE25
Manufacturer
INTERACOUSTICS A/S, ASSENS
Date Cleared
2003-03-28
(85 days)
Product Code
EWO
Regulation Number
874.1050Why did this record match?
Applicant Name (Manufacturer) :
INTERACOUSTICS A/S, ASSENS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.
Device Description
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K Number
K022728Device Name
AUDIOTRAVELLER, MODEL AA222
Manufacturer
INTERACOUSTICS A/S, ASSENS
Date Cleared
2002-10-11
(56 days)
Product Code
ETY
Regulation Number
874.1090Why did this record match?
Applicant Name (Manufacturer) :
INTERACOUSTICS A/S, ASSENS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Interacoustics Audio Traveller AA222 is intended for use by trained operators in hospitals, nurseries, ENT clinics and audiology offices in conducting diagnostic hearing evaluations and assisting in diagnosis of possible otologic disorders. The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.
Device Description
The AA222 is a combination of audiometer and tympanometer, which reduces the amount of equipment necessary.
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