Phase II Study of the Multichannel Auditory Brain Stem Implant for Deafness Following Surgery for Neurofibromatosis 2

OBJECTIVES: I. Define the tonotopocity of multichannel brain stem stimulation and use this information to better program the auditory brain stem implant for an individual.

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.

Completed

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Key information

Conditions

Neurofibromatosis 2 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Cranial Nerve Neoplasms Disease Attributes Ear Diseases Genetic Diseases, Inborn Hearing Disorders Hearing Loss Heredodegenerative Disorders, Nervous System Mental Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Nervous System Neoplasms Neurilemmoma Neurocutaneous Syndromes Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neurofibroma Neurofibromatoses Neurologic Manifestations Neuroma Neuroma, Acoustic Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Neoplasms Rare Diseases Retrocochlear Diseases Sensation Disorders Signs and Symptoms Vestibulocochlear Nerve Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Confirmed diagnosis of neurofibromatosis type 2 Scheduled to undergo first side or second side tumor removal First side implantation performed only on patients with onset of symptoms prior to age 40 --Prior/Concurrent Therapy-- If a nonfunctional auditory brain stem implant (ABI) is present (implanted during the removal of a first side tumor), a multichannel ABI may be implanted during the removal of a second side tumor --Patient Characteristics-- English is the primary language

Treatment and study plan

Multichannel Auditory Brain Stem Implant

Device

Sponsors and collaborators

Lead sponsor

FDA Office of Orphan Products Development

Fed

Collaborators

Cochlear

Registry information

Important dates

Study start: 1999
Study completion: 2000
First posted: Oct 19, 1999
Registry last updated: Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed