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510(k) Data Aggregation

    K Number
    K042017
    Device Name
    BAHA DIVINO
    Manufacturer
    ENTIFIC MEDICAL SYSTEMS, INC.
    Date Cleared
    2004-08-26

    (30 days)

    Product Code
    LXB
    Regulation Number
    874.3302
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTIFIC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BAHA Divino is intended for the following patients and indications: - Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone conduction threshold should be better than or equal to 45 dB HL (measured at 0.5, 1, 2 and 3 kHz) - Bilateral fitting of the Divino is intended for patients who suffer from moderate to severe bilateral symmetric conductive and/or mixed hearing losses. Symmetric bone conductive thresholds are defined as less than 10 dB in average (measured at 0.5, 1, 2 and 4 kHz) or less than 15 dB at individual frequencies - The single sided deafness (SSD) indication for the Divino hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.
    Device Description
    The BAHA Divino is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the Divino is based on a bone conduction technology. The Divino hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.
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    K Number
    K021837
    Device Name
    BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
    Manufacturer
    ENTIFIC MEDICAL SYSTEMS, INC.
    Date Cleared
    2002-08-30

    (87 days)

    Product Code
    LXB
    Regulation Number
    874.3302
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTIFIC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of BAHA hearing aid for SSD is intended to improve speech recognition. The single sided deafness (SSD) indication for BAHA hearing aid is intended for patients who suffer from unilateral sensorineural deafness on one ear while the other ear has normal hearing. Normal hearing is defined as PTA AC threshold equal to or better than 20dB measured at 0.5, 1, 2 and 3 kHz. BAHA for SSD is also indicated for patients who are indicated for an AC CROS but who for some reason cannot or will not use an AC CROS.
    Device Description
    The BAHA is a bone conduction-type hearing aid. Unlike conventional hearing aids, which depend on acoustic coupling through the air, the BAHA is based on a bone conduction technology. The BAHA hearing aid is connected to a fixture pillar, which has been surgically placed in the bone behind the deaf ear. Sound is transmitted through the bones of the skull to the hearing ear with the normal functioning cochlea.
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    K Number
    K011438
    Device Name
    BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
    Manufacturer
    ENTIFIC MEDICAL SYSTEMS, INC.
    Date Cleared
    2001-07-23

    (74 days)

    Product Code
    LXB
    Regulation Number
    874.3302
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTIFIC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K002913
    Device Name
    HEADBAND FOR BAHA
    Manufacturer
    ENTIFIC MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-10-17

    (29 days)

    Product Code
    LXB
    Regulation Number
    874.3302
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTIFIC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992872
    Device Name
    BRANEMARK BONE-ANCHORED HEARING AID (BAHA) CORDELLE II
    Manufacturer
    ENTIFIC MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-11-24

    (90 days)

    Product Code
    LXB, 77L
    Regulation Number
    874.3302
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENTIFIC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification. Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45dB HL. The nominal output from the BAHA Cordelle II is on average 13 dB stronger than the Classic 300 model (measured at 0.5,1,2,3 kHz). The Cordelle is recommended for patients having the same indications for the Classic 300 but where slightly stronger amplification is needed than what is delivered by the Classic 300 model. (Patients with bone conduction thresholds better than 45dB HL will be expected to improve, but may not activeve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following: 1. Chronic otitis media (COM); or 2. Congenital malformation (CM) of the middle/external ear; or 3. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid. Additional indications to be met by perspective BAHA™Cordelle II candidates: 1. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian. 2. For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.
    Device Description
    The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, vanous accessories necessary for the placement and use of the fixture/abutment pillar, a sound processor which is attached to the abutment and a body worn unit which has two potentiometers that control threshold knee and loundness boost and a tone control switch. The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle IEjs a sound processor system which consists of two units; a transducer and a body worn unit. The body worn unit has two potentiometers which control threshold knee and loudness boost and a tone control switch. Transducer: The transducer is an at-the-ear level sound processor which uses a direct connection to the skull bone without intervening skin and soft tissue. The transducer is attached to a snap coupling titanium abutment, which is fastened to a titanium flange fixture using a gold screw. The transducer is connected to a body worn unit via a cord with electrical output and input connectors. Body Worn Unit: As noted previously the body worn unit has two potentiometers which control the threshold knee and loudness boost. The unit is also equipped with an electrical input to receive signals from a "Walkman" FM/IR system. When the electrical contact is connected it overrides the telecoil signal. The body worn unit has a tone switch which controls the frequency response. The switch can be set in three different positions. N= Normal, which gives the widest frequency response. H= High frequency emphasis (reduction of low frequency sounds). L= Low frequency emphasis (reduction of high frequency sounds). The tone switch is effective for all inputs (microphone, telecoil, electrical). The two trim controls marked LB and TK can be adjusted with a small screwdriver by the patient's audiologist. The LB adjusts the gain for loud sounds and the TK adjusts the gain for soft sounds. The body worn unit is equipped with a clip so you can attach the unit to the patient's clothing (i.e. shirt/blouse pocket ... ). Abutment Snap: There is an abutment snap which is mounted to the transducer. It is designed to snap into the abutment and hold the transducer securely in place. Abutment Insert: The function of the abutment insert is to act as a guide for the abutment snap. It makes it easier to connect the transducer to the abutment. It also protects the inside of the abutment from dirt. Abutment and Abutment Screw: The abutment is a replaceable percutancous connection between the fixture and the external sound processor which is partially or totally submerged into soft tissue. The abutment is made of titanium and is fastened to the fixture via an internal an abutment screw. Abutment Cover: When the transducer is not in place you can attach the abutment cover on the abutment to make it look more aesthetically pleasing. One can attach the cover by pressing it into place on the abutment. Fixture: The fixture is a threaded titanium screw which is implanted into the temporal bone and intended to provide permanent bone anchorage as a means to attach the sound processor. Cover Screw and Healing Cap: The cover screw and healing cap are temporary components utilized only during the healing periods post surgical placement of the titanium fixture. The cover screw is used during the first healing period and is arrached to the fixture and covered with the soft tissue during the healing of the bone and soft tissue. The covers the upper part of the internal threads of the fixture. Thus, the cover screw will preclude bone and soft tissue from growing into the site where the abutment will be placed. The healing cap is used during the second healing period and covers the abutment surface. These components are used only during the healing stages of the surgery and remain in place for three to four months and one to two weeks respectively.
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