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510(k) Data Aggregation
K Number
K093715Device Name
EVOK 900 SERIES HEARING AID/TINNITUS MASKER OPTION DEVICE
Manufacturer
Date Cleared
2010-12-22
(386 days)
Product Code
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
MAGNATONE HEARING AID CORP. DBA PERSONA MEDICAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Evok series is designed for use in sound therapy for tinnitus retraining therapy, masking, or other recognized forms of tinnitus treatment. Sound therapy should be used in concert with counseling from a physician, an audiologist or other qualified tinnitus specialists.
The target population for this product is primarily the adult population 18 vears of age and older. The target group for this product includes individuals reporting tinnitus who can also benefit from an air conduction hearing aid.
Device Description
Our devices are a combination of a hearing aid and a tinnitus masker in the same instrument. They are prescribed for those people with hearing loss who do not have significant relief with a hearing aid alone.
Dispenser or user adjustments permit selection of broad band or high or low frequency emphasis noise and aid response. It is essentially a tinnitus masker with a hearing aid added. Programmable volume controls are provided: one for noise level and the other for hearing aid gain. The dispenser, audiologist or user can mix the amount of noise and amplification as required.
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