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510(k) Data Aggregation
K Number
K972039Device Name
NEW SOUND HIDDEN AID COMPLETELY IN CANAL (CIC)
Manufacturer
Date Cleared
1997-08-25
(84 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
NU-SOUND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in the following category(ies): Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low tolerance To Loudness, Peak Clipping.
Device Description
The device is an air conduction hearing aid. It is a prosthetic device worn in the ear canal to amplify sound. The shell is made using light cure materials and process. Various electronic components are utilized depending upon the type of circuitry needed.
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