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510(k) Data Aggregation
K Number
K130514Device Name
AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT
Manufacturer
AUDIFON-USA INC.
Date Cleared
2013-11-21
(267 days)
Product Code
KLW, ESD
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
AUDIFON-USA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The combined devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who also need or desire amplification. The amplification suits the needs of a of a slight to a profound hearing loss (see table below). The products may also be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Device Description
The above mentioned TRT devices are digital noise generators and hearing aids which were developed to be used in a tinnitus retraining therapy. These products have up to four different programs, which can be programmed in shape and level to fit the individual users needs. The programming can be done with a standard HI-PRO and the audifit software. Within the software the amplification of the combi-masker can be fitted to the individual needs. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC, IS+ housing) or in a standard behind-the-ear instrument housing (S, S+, M and X housing).
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K Number
K130417Device Name
AUDIFON SUENO CIC, AUDIFON SUENO S, AUDIFON SUENO T CIC, AUDIFON SUENO T S
Manufacturer
AUDIFON-USA INC.
Date Cleared
2013-09-12
(205 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
AUDIFON-USA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The devices are intended for the adult population suffering from a chronic persistent ringing in the ears (Tinnitus), who do not need or desire amplification. The products may be used for masking Tinnitus as part of a Tinnitus Retraining Therapy (TRT) protocol and should be utilized only in consultation with a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist.
Device Description
The audifon sueno devices are digital noise generators which were developed to be used in a tinnitus retraining therapy. These products have one program, which can be programmed in shape and level to fit the individual user's needs. The programming can be done with a standard HI-PRO and the audifit software. The noise can be adjusted in shape with low- and high-cut filters and in the output level. It is housed in a standard In-the-ear instrument housing (CIC housing) or in a standard behind-the-ear instrument housing (S housing). The audifon sueno T devices (sueno T S and sueno T CIC) can be additional adjusted with three trimmer potentiometers by the hearing healthcare professional.
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K Number
K121793Device Name
AN EVO 1, CS EVO 1, CONTACT MINI, APOLLON
Manufacturer
AUDIFON-USA INC.
Date Cleared
2012-11-01
(135 days)
Product Code
LXB
Regulation Number
874.3302Why did this record match?
Applicant Name (Manufacturer) :
AUDIFON-USA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bone conduction hearing aids by BHM-Tech are wearable sound-amplifying devices intended to compensate impairments in personal hearing. The fundamental operating principle is to receive, amplify, and transfer sound via the skin and the bone of the skull to the inner ear of a hearing impaired person. The amplification suits the needs of a mild to a moderate hearing loss. They require individual fitting in performance executed by a hearing aid professional.
The target populations for the devices are as follows:
AN-Evo1 adults and children (≥ 12 years)
contact star evo1 adults and children (≥ 12 years)
contact mini adults and children (≥ 8 months)
apollon adults and children (≥ 12 years)
The apollon is a device where it is capable of utilizing either air or bone conduction.
Device Description
AN-Evo1: Different to the more common air conduction hearing devices, with digital bone conducted hearing aids AN-Evo1 the sound is produced in a small vibrator and transmitted by direct contact to the mastoid. From here the sound is transmitted via the skull to the inner ear and transformed directly into nerve impulses. The AN-Evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aidfronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The AN-Evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples. The AN-Evo1 includes a digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O, OFF, T. Telecoil (induction coil) and M. Microphone. A Volume Control wheel is used to adjust the output power of the device. The AN-Evo1 is programmable via the HIPRO-Programming Box and BHMFit2 Fittingsoftware. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
contact star evo1: Different to traditional air conduction hearing devices, by using bone conduction hearing aids contact star-evo1 the sound is produced in a broadband miniature vibration receiver and transmitted by direct skin contact to the mastoid, the area of the temple bone behind the ear. From here it is transmitted through the skull to the inner ear, where it is transformed into nerve impulses. The contact star evo1 is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different aid front-models. For mounting, extension tips and aid-fronts with different mechanical dimensions (lengths of extension tips, size of aid-fronts) are available. The contact star evo1 is also available in different colors (black, brown and anthracite). It can be used monaural or binaural. For monaural, the hearing aid has one active temple and one none-active temple (dummy-temple). For binaural, the hearing aid has two active temples. The contact star evo1 includes a high performance digital programmable amplifier and a bone vibrator unit, which are connected directly in one housing. The bone vibrator of the device is held against the head and is driven electrically by the amplifier to transmit the amplified sound as vibrations to the underneath bones of the skull. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. For selecting the operating mode, a three position mode switch is used. The positions are O..OFF, T.Telecoil (induction coil) and M..Microphone. A Volume Control wheel is used to adjust the output power of the device. The contact star evo1 is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
contact mini: The contact mini is a digital bone conduction hearing aid. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear. Contact mini consists of two interconnected units. An amplifier module and an bone vibrator. The amplifier module and the bone vibrator are connected through a wire cable. The amplifier module amplifies the sound and the bone vibrator converts them into vibrations. The bone vibrator has direct contact with the skin. The amplified sound moves through the bones of the inner ear, where it is directly converted into a neural stimulus. The contact mini is a hearing aid battery powered, programmable, digital, bone conduction hearing aid which can be mounted onto different wearing such as headband, circlets and baseball caps. The contact mini is also available in different colors (black, blue and red). It can be used monaural or binaural. For monaural, the hearing aid use one active device and one bone vibrator. For binaural, the hearing aid uses two active devices and two bone vibrators. The contact mini includes a high performance digital programmable amplifier. The amplifier module is completely self-contained and has also a built in microphone for picking up sound. A Volume Control trimmer is used to adjust the output power of the device. The contact mini is programmable via the HIPRO-Programming Box and BHMFit2 programming software. The fitting will only be conducted by an audiologist, a hearing aid specialist or ENT.
apollon: The apollon is also a bone conduction hearing aid. Unlike conventional hearing aids which depend upon acoustic coupling through air, the apollon is based on bone conduction technology. Sound is transmitted directly through the bones of the cochlea, bypassing the outer and middle ear. The apollon consists of a bone vibrator unit, a shirt pocket sized amplifier module and a wire cable for connecting the bone vibrator with the amplifier module. The bone vibrator is a convenient sized unit that is held against the head and is driven electrically to transmit the amplified sound as vibrations to the underneath bones of the skull. The amplifier module connects the bone vibrator through the wire cable and usually would be carried in the users pocket. The amplifier module is completely self-contained and is battery powered. It also has a built in microphone for picking up sound and a built in induction coil for picking up magnetic fields from induction loop systems. As an added feature an auxiliary 3.5mm input jack allows the user to connect the apollon directly to TV, MP3 players, portable radios or even telephones without any additional adaptors. For selecting the operating mode, a four position mode switch is used. The positions are O..OFF, T..telecoil (induction coil), MT..microphone & telecoil (induction coil) and M..microphone. A Volume Control is used to adjust the output power of the device. Also, the possibility of a connection between via the DAI (Direct Audio Input) is available. A red LED (Light Emitting Diode) is used for optical low battery warning. The apollon is equipped with an high performance digital programmable amplifier system which can be adjusted via the BHMFit2 Programming software. The fitting will only be conducted by an audiologist, an hearing aid specialist or ENT.
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K Number
K083488Device Name
JUMP S+ TRT, JUMP CIC TRT, JUMP S TRT, JUMP C TRT
Manufacturer
AUDIFON-USA INC.
Date Cleared
2009-02-19
(86 days)
Product Code
KLW
Regulation Number
874.3400Why did this record match?
Applicant Name (Manufacturer) :
AUDIFON-USA INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The jump C TRT is addressed to the adult population with a chronological persistent ringing in the ears (Timitus), who do not need or desire amplification. It may be used for masking timitus as part of tinnitus management program that is prescribed by a licensed hearing healthcare professional, who is trained in subsequent rehabilitation therapy, or a qualified audiologist. Therefore it generates a broadband noise with sufficient bandwidth and intensity and is applied on the ear.
Device Description
The jump C TRT is an analog noise generator that was developed to be used in a tinnitus retraining therapy. This product has a variable output level and an adjustable low-cut filter for a custom-tailored noise shape, which fits the individual user. It is housed in a standard housing for cymba application.
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