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Found 6 results
510(k) Data Aggregation
K Number
K972106Device Name
PHONAK NOVO FORTE E3
Manufacturer
Date Cleared
1997-08-15
(71 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHONAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
General Indications: A. The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight, X 2. Mild, X 3. Moderate, X 4. Severe, 5. Profound. Configuration: X 1. High Frequency - Precipitously Sloping, X 2. Gradually Sloping, X 3. Reverse Slope, X 4. Flat, 5. Other. Other: X 1. Low tolerance To Loudness, 2., 3. B. Specific Indications (only if appropriate.): (Most psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - l. 2. - 3.
Device Description
Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments
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K Number
K972105Device Name
PHONAK EPICA
Manufacturer
Date Cleared
1997-08-01
(57 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHONAK, INC.
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 far 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, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance To Loudness
Device Description
Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments.
Features: Two programmable memories, 3 choices of signal processing, optional remote control
Assembly: Assembled from components available to hearing instruments manufacturer. Delivered completely assembled to the hearing aid dispenser
Technical Characteristics: Technical specifications comply with ANSI S3.22 - 1987
Audiometric Fit: Frequency response, gain, and output are fitted to the individual audiogram
Controls: Operated with remote control
Power Source: Standard hearing instrument battery, size 312
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K Number
K972097Device Name
PHONAK MICROZOOM P 2
Manufacturer
Date Cleared
1997-07-30
(56 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHONAK, INC.
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 far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: X 1. Slight X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness
Device Description
Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
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K Number
K964035Device Name
PHONAK MICROLINK, PERSONAL FM RECEIVER
Manufacturer
Date Cleared
1996-12-04
(57 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHONAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.
Device Description
Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.
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K Number
K961653Device Name
PHONAK SONA P2
Manufacturer
Date Cleared
1996-05-29
(29 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHONAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To amplify and transmit sound to the ear
Device Description
Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments
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K Number
K961622Device Name
PHONAK PICONET2 P2 AZ
Manufacturer
Date Cleared
1996-05-17
(21 days)
Product Code
Regulation Number
874.3300Why did this record match?
Applicant Name (Manufacturer) :
PHONAK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To amplify and transmit sound to the ear
Device Description
Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments
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