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II. Optimize device fitting by combining monopolar and bipolar stimulation, and individual psychoacoustic channels for each patient, to increase the number of usable information channels for each patient and reduce or eliminate undesirable side effects.
III. Evaluate performance and learning effects using optimized fitting procedures.
PROTOCOL OUTLINE: Patients undergo surgery to remove the first side or second side tumor, during which the multichannel auditory brain stem implant is implanted. Initial stimulation is conducted 4-6 weeks after surgery.
Patients are followed every 3 months for the first year, then annually thereafter.
Primary Purpose: Treatment
Multichannel Auditory Brain Stem Implant
FDA Office of Orphan Products Development
Published on BioPortfolio: 2014-08-27T03:58:14-0400
This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.
The objectives of the clinical study are to implant five deaf patients (those with Neurofibromatosis Type II, NF2) with a new two-shank auditory midbrain implant array (AMI; developed by C...
The Nucleus 24 Auditory Brainstem Implant (ABI) is the only FDA approved device for restoration of meaningful hearing in Neurofibromatosis Type 2 (NF2) patients. This device has been disco...
Although cochlear implants can restore hearing to individuals who have lost cochlear hair cell function, there is no adequately effective treatment for individuals suffering chronic imbala...
Tinnitus is the perception of sound or noise in the absence of an external physical source. It is a highly prevalent condition and for a high percentage of patients, there is no satisfying...
Electrically evoked auditory brainstem responses (EABR) guide placement of the multichannel auditory brainstem implant (ABI) array during surgery. EABRs are also recorded under anesthesia in nontumor ...
Objective speech recognition tasks are widely used to measure performance of adult cochlear implant (CI) users; however, the relationship of these measures with patient-reported quality of life (QOL) ...
Functional brain alterations in auditory hallucination subtypes in individuals with auditory hallucinations without the diagnosis of specific neurological diseases and mental disorders at the current stage.
We explored common and distinct pathological features of different subtypes of auditory hallucinations (AHs) to elucidate the underlying pathological mechanisms.
To evaluate long-term language development in children with prelingual deafness who received auditory brainstem implants (ABIs) compared with children who received cochlear implants (CIs) at the same ...
Microsleeps are brief episodes of arousal level decrease manifested through behavioral signs. Brain activity during microsleep in the presence of external stimulus remain poorly understood. In this st...
Surgical insertion of an electronic hearing device (AUDITORY BRAIN STEM IMPLANTS) with electrodes to the cochlea nucleus in the BRAIN STEM rather than to the inner ear as in COCHLEAR IMPLANTATION.
Electrical waves in the CEREBRAL CORTEX generated by BRAIN STEM structures in response to auditory click stimuli. These are found to be abnormal in many patients with CEREBELLOPONTINE ANGLE lesions, MULTIPLE SCLEROSIS, or other DEMYELINATING DISEASES.
Multi-channel hearing devices typically used for patients who have tumors on the COCHLEAR NERVE and are unable to benefit from COCHLEAR IMPLANTS after tumor surgery that severs the cochlear nerve. The device electrically stimulates the nerves of cochlea nucleus in the BRAIN STEM rather than the inner ear as in cochlear implants.
The brain stem nucleus that receives the central input from the cochlear nerve. The cochlear nucleus is located lateral and dorsolateral to the inferior cerebellar peduncles and is functionally divided into dorsal and ventral parts. It is tonotopically organized, performs the first stage of central auditory processing, and projects (directly or indirectly) to higher auditory areas including the superior olivary nuclei, the medial geniculi, the inferior colliculi, and the auditory cortex.
Hearing loss due to disease of the AUDITORY PATHWAYS (in the CENTRAL NERVOUS SYSTEM) which originate in the COCHLEAR NUCLEI of the PONS and then ascend bilaterally to the MIDBRAIN, the THALAMUS, and then the AUDITORY CORTEX in the TEMPORAL LOBE. Bilateral lesions of the auditory pathways are usually required to cause central hearing loss. Cortical deafness refers to loss of hearing due to bilateral auditory cortex lesions. Unilateral BRAIN STEM lesions involving the cochlear nuclei may result in unilateral hearing loss.
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Hearing, auditory perception, or audition is the ability to perceive sound by detecting vibrations, changes in the pressure of the surrounding medium through time, through an organ such as the ear. Sound may be heard through solid, liquid, or gaseous mat...
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