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Found 5 results
510(k) Data Aggregation
K Number
K973885Device Name
OTICON DIGISOUND ITE
Manufacturer
OTICON, INC.
Date Cleared
1997-11-04
(21 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
OTICON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope 4. Flat ✓ 5. Other Other 1. Low tolerance To Loudness ✓ 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise. must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.
Device Description
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K Number
K973886Device Name
OTICON DIGISOUND COMPACT
Manufacturer
OTICON, INC.
Date Cleared
1997-11-04
(21 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
OTICON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 ability. These 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 ✓ 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other 1. Low tolerance To Loudness ✓ 2. 3. B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) 1. To amplify and deliver sound to the ear via air conduction 2. 3.
Device Description
Not Found
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K Number
K964683Device Name
DIGIFOCUS ITE
Manufacturer
OTICON, INC.
Date Cleared
1996-12-12
(20 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
OTICON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To amplify and deliver sound to the ear
Device Description
DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm.
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K Number
K961059Device Name
DIGIFOCUS COMPACT
Manufacturer
OTICON, INC.
Date Cleared
1996-05-07
(50 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
OTICON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To amplify and deliver sound to the ear
Device Description
DigiFocus Compact (DFC) is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 54 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm. Technical specifications are in accordance with ANSI Standards S3.22-1987. Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data. All parameters are digitally programmed via software. The hearing aid has a manual OTM switch. Standard type 13 battery.
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K Number
K960284Device Name
OTICON /PRIMOFOCUS (PF)
Manufacturer
OTICON, INC.
Date Cleared
1996-03-07
(48 days)
Product Code
ESD
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
OTICON, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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