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510(k) Data Aggregation
K Number
K123701Device Name
HEARLAB ACA
Manufacturer
FRYE ELECTRONICS, INC.
Date Cleared
2013-04-05
(123 days)
Product Code
GWJ
Regulation Number
882.1900Why did this record match?
Applicant Name (Manufacturer) :
FRYE ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device).
Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.
These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.
Device Description
Not Found
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K Number
K093006Device Name
FONIX ,MODEL 8000
Manufacturer
FRYE ELECTRONICS, INC.
Date Cleared
2009-12-30
(93 days)
Product Code
ETW
Regulation Number
874.3310Why did this record match?
Applicant Name (Manufacturer) :
FRYE ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device performs electro-acoustical, telecoil, and battery current measurements of hearing aids.
Device Description
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K Number
K022510Device Name
FONIX, MODEL 7000
Manufacturer
FRYE ELECTRONICS, INC.
Date Cleared
2002-08-27
(28 days)
Product Code
ETW
Regulation Number
874.3310Why did this record match?
Applicant Name (Manufacturer) :
FRYE ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient. If the patient wears a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box.
Device Description
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K Number
K980377Device Name
FONIX FP35 HEARING AID ANALYZER
Manufacturer
FRYE ELECTRONICS, INC.
Date Cleared
1998-03-18
(44 days)
Product Code
ETW
Regulation Number
874.3310Why did this record match?
Applicant Name (Manufacturer) :
FRYE ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is not applied to a patient for any direct treatment of any illness or condition. It is not prescribed or used as an over the counter device. It is not used by a patient.
If the patient wears or wishes to wear a hearing aid, then the device may be used to determine the electroacoustic performance of the hearing aid when worn by the patient or as tested in a coupler/sound box. The device can also present sound to the patient's ear in a test to determine his psychoacoustic comfort levels.
Device Description
Fonix FP35 Hearing Aid Analyzer
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