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The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications: · Patients 12 years of age or older. · Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) should be better than or equal to 45 dB HL. · Bilateral fitting of the BONEBRIDGE is intents having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies. · Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). · The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. · Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.

The BCI Lifts are optional accessories that can be implanted together with the BONEBRIDGE Bone Conduction Implant (model BCI 601 or BCI 602). They are attached to the fixation wings of the BCI and serve as a spacer to increase the distance between the fixation wings and the skull bone. The devices can be used if the necessary drill depth for the BCI implant cannot be achieved for anatomical reasons. They are attached to the fixation wings of the BCI implant to reduce the necessary drill depth for the Bone Conduction - Floating Mass Transducer (BC-FMT) in the skull bone.

The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting, and single-sided deafness. INDICATIONS: The Bonebridge bone conduction hearing implant system is intended for the following patients and indications: - Patients 12 years of age or older. - Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3kHz) should be better than or equal to 45 dB HL. - Bilateral fitting of the Bonebridge is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3kHz, or less than 15 dB at individual frequencies. - Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3kHz). - The Bonebridge for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. - Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.

The MED-EL BONEBRIDGE System augments hearing by providing acoustic input to the inner ear via bone conduction. The MED-EL BONEBRIDGE System consists of two major components: The implant, called Bone Conduction Implant (BCI) and the external audio processor, e.g. the SAMBA 2 BB. The SYMFIT 8.0 software enables the fitting and configuration of the SAMBA 2 BB audio processor and is indicated for professional use only, i.e. used by hearing healthcare professionals during a fitting session of the external audio processor SAMBA 2 BB. Additionally, the SAMBA 2 GO and SAMBA 2 Remote are also subject to this 510(k). Both devices offer a convenient option to adjust simple, pre-defined settings of the compatible SAMBA 2 BB audio processor. Additionally, the SAMBA 2 GO can also be used as an assistive streaming device. The MED-EL BONEBRIDGE System is an active implantable bone conduction hearing system. The MED-EL BONEBRIDGE System is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.

INTENDED USE: The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting, and single-sided deafness. INDICATIONS: The Bonebridge bone conduction hearing implant system is intended for the following patients and indications: - Patients 12 years of age or older. - Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) should be better than or equal to 45 dB HL. - Bilateral fitting of the Bonebridge is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz, or less than 15 dB at individual frequencies. - Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). -The Bonebridge for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. - Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.

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The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications: - · Patients 12 years of age or older. · Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5,1, 2, and 3 kHz) should be better than or equal to 45 dB HL. · Bilateral fitting of the BONEBRIDGE is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5. 1, 2. and 3 kHz, or less than15 dB at individual frequencies. · Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at0.5, 1, 2, and 3 kHz). · The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. · Prior to receiving the device, it is recommended that an individual have experience with appropriately fit air conduction or bone conduction hearing aids.

BONEBRIDGE augments hearing by providing acoustic input to the inner ear via bone conduction. BONEBRIDGE consists of the following components: The Bone Conduction Implant (BCI) and the externally worn audio processor. The BCI 601 implant is provided in an implant kit together with two templates to determine optimal implant placement, one drill bit, two regular cortical titanium screws (gold surface) and one emergency screw (blue surface). All devices are shipped in one sterile tray and are for single-use only. The Bone Conduction Implant (BCI) is the implantable part of BONEBRIDGE and can only be used together with compatible MED-EL external components. The device is an osseointegrated bone conduction implant system, intended to provide a level of useful sound perception for individuals with conductive and mixed hearing loss, as well as those suffering from single-sided deafness. The BCI is surgically implanted into the mastoid bone. The BCI 601 has two main sections, the coil section and the transducer section. The BCl 601 consists of a magnet surrounded by the receiver coil, the electronics (demodulator), the transition and the Bone Conduction - Floating Mass Transducer (BC-FMT). The BCI 601 is activated by placing the external audio processor over the magnet of the BCI 601. The signal and the energy to drive the BC-FMT are transferred via an inductive link to the internal coil, processed by the demodulator and then relayed to the BC-FMT. The BC-FMT transduces the signal into mechanical vibrations, which are conducted to the mastoid bone via the cortical titanium screws. These vibrations stimulate the auditory system through the bone conduction pathway to allow the patient to hear.

The BONEBRIDGE bone conduction hearing implant system is intended for the following patients and indications: - Patients 12 years of age or older. - Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL. - . Bilateral fitting of the BONEBRIDGE is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies. - Patients who have profound sensorineural hearing loss in one ear and normal hearing . in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz). - . The BONEBRIDGE for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS. - . Prior to receiving the device, it is recommended that an individual have experience with appropriately fit air conduction or bone conduction hearing aids.

The BONEBRIDGE consists of a Bone Conduction Implant that is surgically implanted in the mastoid bone and an external Audio Processor that is held in place on the patient's scalp by magnetic attraction between the implant and the Audio Processor (Figure 1).

The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband or an adhesive adapter that is placed behind the auricle. Indications: · Unilateral or bilateral conductive hearing loss, either chronic or temporary. The pure tone average bone-conduction hearing threshold (measured at 0.5. 1. 2, and 3 kHz) should be better than or equal to 25 dB HL. · Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL

The ADHEAR system includes a bone conduction audio processor that can be retained on the head with an adhesive adapter or by the headband situated over the mastoid behind the auricle. The ADHEAR system is intended to be used during waking hours. While the adhesive adapter is attached to the skin for 3 to 7 days and then replaced, the audio processor is removed at night. Both the audio processor and the adhesive adapter are necessary components for the system to work. Together the components work as one system to deliver vibrations to the mastoid bone in order to conductively transmit sound to the inner ear for patients with conductive hearing loss or single sided deafness via bone conduction. The ADHEAR system consists of an adhesive adapter sitting behind the auricle and an audio processor mounted on the attachment. The audio processor contains microphones and signal processing technology as well as a battery. It detects, processes, amplifies and finally transmits sound to the adhesive adapter which transmits vibrations to the mastoid which conducts sounds to the inner ear. The audio processor is equipped with a push button that allows the user to switch between 4 pre-defined settings. A colour sleeve is provided for pediatric use. It features a tamper-proof battery door and dampens potential drops of the processor unit. The ADHEAR system contains the following components: - . ADHEAR Audio Processor (model 701) - Package of ADHEAR Adhesive Adapters - . ADHEAR Positioning Tool - ADHEAR Headband - . Retention clip - ADHEAR Sleeves