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510(k) Data Aggregation
K Number
K972755Device Name
V-12 LONG LIFE 675 HEARING AID
Manufacturer
Date Cleared
1997-08-05
(14 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
VISTA LABS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A. General Indications: 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 the following category(ies). (Check appropriate space(s)): Severity: ✓ 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
Device Description
ITE Hearing Aid - substantially equivalent to other in-the-ear (ITE) hearing aids. Features: 675 Long Life battery using a 675 size battery pill in an ITE Hearing Aid, with Class D battery size gives the benefit of extended battery life for this style of hearing instrument. Assembly: Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical Characteristics: Technical specifications were obtained in accordance with S3.22-1987 ANSI Specifications Preliminary data sheets for the Vista V-12 Long Life models are enclosed Fit: The frequency response of this product is dictated by the individual audiogram from each client. Power: Standard 675 size hearing aid battery. A user's manual and other information is supplied with each hearing aid.
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K Number
K970939Device Name
VISTA V-38 CIC
Manufacturer
Date Cleared
1997-06-06
(85 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
VISTA LABS
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 the following category(ies). (Check appropriate space(s):
Severity: Slight, Mild, Moderate, Severe
Configuration: High Frequency Precipitously Sloping, Flat
Other: Low tolerance to loudness
Device Description
The Vista completely in the canal (CIC) is a small instrument designed to fit competely in the ear canal. The volume control is a standard screw-set control and uses a #10A or 5A battery. The CIC fit reduces residual ear canal volume and results in the need for less gain, decreased chance of feedback, improvement of high frequency gain, decreased occlusion effect, and lesser self-masking. The CIC's circuits are assembled into a variety of different configurations including Class D, K-amp, and RGA Class A. Assembled from standard components which are widely utilized by other hearing aid manufacturers. Technical specifications comply with S3.22-1987 ANSI Specifications. Dispenser controlled Volume Control. The frequency response of this product is dictated by the individual audiogram from each client. Standard hearing aid battery.
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