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510(k) Data Aggregation
K Number
K973880Device Name
SONIX HEARING AID FITTING AND PROGRAMMING SYSTEM
Manufacturer
SONIX TECHNOLOGIES, INC.
Date Cleared
1998-01-12
(90 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
SONIX TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.
Device Description
The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data.
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