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510(k) Data Aggregation
K Number
K970665Device Name
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
Manufacturer
WILLIAMS SOUND, LLC
Date Cleared
1997-05-02
(70 days)
Product Code
EPF, LZI
Regulation Number
874.3320Why did this record match?
Applicant Name (Manufacturer) :
WILLIAMS SOUND, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To improve the signal to noise ratio for a listener ir a var ety of ur vironments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilition of Central Auditory Processing Disorders, amplification for mild to moderate conductive and senonineural hearing loss, and amplification moderate to severe conductive and sensorineural bearing loss when used in conjunction with a personal hearing aid.
Device Description
Not Found
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K Number
K970687Device Name
WILLIAMS SOUND, PERSONAL FM, HEARING HELPER
Manufacturer
WILLIAMS SOUND, LLC
Date Cleared
1997-05-02
(67 days)
Product Code
EPF, LZI
Regulation Number
874.3320Why did this record match?
Applicant Name (Manufacturer) :
WILLIAMS SOUND, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To improve the signal to noise ratio for a listener in a variety of environments where background noise, the interest poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the list the find of open condification for Atention Deficit Disorders, Leaming De the the for the the for the Central Autory Processing Disorders, amplification for midd to moderate sombetive and sensiblities, hearing loss, and amplification for mild to moderate conductive and senso hearing loss, and amplification for mild to moderate conductive and sensorineural conjunction with a personal heating and sensorineural hearing loss when used in conjunction with a personal hearing aid.
Device Description
WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 100 / PFM 200
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K Number
K970974Device Name
WILLIAMS SOUND, PERSONAL FM SYSTEM, HEARING HELPER
Manufacturer
WILLIAMS SOUND, LLC
Date Cleared
1997-05-02
(46 days)
Product Code
LZI
Regulation Number
874.3320Why did this record match?
Applicant Name (Manufacturer) :
WILLIAMS SOUND, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies). (Check appropriate space(s)): Severity: Slight, Mild, Moderate. Configuration: Gradually Sloping, Flat.
Specific Indications: FOR IMPROVED SIGNAL TO NOISE RATIO THROUGH PLACEMENT OF A REMOTE MICROPHONE NEAR A DESIRED SOUND SOURCE. SEVERE TO PROFOUND LOSS - USED IN CONJUNCTION WITH PERSONAL HEARING AID VIA TELECOIL OR DIRECT AUDIO INPUT.
To improve the signal to noise ratio for a listener in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.
Device Description
HEARING HELPER PERSONAL FM SYSTEM Models PFM300 & PFM 358. WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 300 / PFM 350.
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