Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01864291
Status:
TERMINATED
Last Update Posted:
2020-06-02
First Post:
2013-05-22
Brief Title:
Auditory Brainstem Implant ABI in Pediatric Non-Neurofibromatosis Type 2 Subjects
Sponsor:
Massachusetts Eye and Ear Infirmary
Organization:
Massachusetts Eye and Ear Infirmary
Study Overview
Official Title:
Study of the Nucleus 24 and ABI541 Auditory Brainstem Implants in Pediatric Non-Neurofibromatosis Type 2
Status:
TERMINATED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed by IRB
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ABI
Brief Summary:
The purpose of this research study is to determine whether Auditory Brainstem Implant ABI can improve hearing in children who are deaf and cannot receive a cochlear implants
Detailed Description:
The goal of this MEEI Auditory Brainstem Implant ABI research study is to find new ways to improve hearing in children who are deaf and cannot receive a cochlear implant The ABI is a surgically placed bionic implant that converts sounds into electrical signals that are directly transmitted to the cochlear nucleus the first auditory center of the brain For many years ABIs have improved the hearing of patients who are deaf due to brain tumors associated with a genetic syndrome called Neurofibromatosis Type 2 NF2 However a number of recent studies suggest that deaf patients who do not have NF2 and are not eligible for a cochlear implant may also benefit from placement of an ABI These preliminary studies suggest that these non-NF2 or nontumor patients may actually have better outcomes after ABI surgery than patients suffering from NF2 Children appear to be particularly good candidates because of their developmental plasticity and in many studies outcomes are more favorable in children that adults Patients who do not have NF2 and are deaf due to abnormalities in their hearing nerves or inner ears from congenital malformations infection disease or injury are not cochlear implant candidates and there are no other options to improve hearing in these cases except for the ABI Thus the purpose of our study is to carefully analyze whether ABI surgery improves the hearing and quality of life of non-NF2 children based on subjective and objective measures of their hearing before and after ABI surgery In particular we plan to study ABI outcomes in non-NF2 pediatric patients characterize the parameters used on their devices and determine the safety profile of ABIs in these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None