Contact Us Today!

617-523-7900

or Use Our Simple Online Form to Give Us Feedback

We welcome your comments and feedback. Please include contact information if you'd like a response.

Did you find this page helpful?





If you would like a response, please include your contact information.

Title
Study of the Nucleus 24 Auditory Brainstem Implant in Pediatric Non-Neurofibromatosis Type 2 Subjects
MEEI Protocol ID
13-028H 
National Clinical Trial (NCT) Number
Condition
Sensorineural Hearing Loss Bilateral Deafness
Sponsor
Daniel Lee, M.D.
Principal Investigator
Daniel Lee, M.D.
Study Design
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Study Objective
To carefully analyze how ABI surgery improves the hearing and quality of life of non-NF2 infants and children based on subjective and objective measures of their hearing before and after ABI surgery.
Who is Eligible
10 pre-linguistic young children (18 mos. to 5 yrs. of age) and 5 post-linguistic children (<18 yrs. of age)
Subject Enrollment
15 children (<18 years of age) with Sensorineural Hearing Loss Bilateral Deafness
Study Procedures
Screening Procedures:
After confirming that potential study participants meet basic demographic inclusion criteria, patients will be evaluated by Dr. Daniel Lee, a pediatric neurotologic surgeon at MEEI. A detailed history will be obtained and physical exam will be completed. Subjects will also be evaluated for baseline qualitative measures using questionnaires and quantitative measures using audiologic testing. In particular, audiometric threshold testing will be completed to determine acoustic auditory status and confirm that all patients have severe to profound deafness. Electrical Auditory Brainstem Response (EABR) evaluation will only be used if the validity of behavioral audiometric testing is in question. These parameters will be compared to inclusion criteria to determine if a subject meets all inclusion criteria and represents a viable candidate for ABI surgery.
 
Enrollment/Baseline Procedures:
All baseline procedures will be completed at the time of screening. In children older than 14 year of age, qualitative measurements using the Abbreviated Profile of Hearing Aid Benefit (APHAB), Modified Hearing Handicap Inventory (HHI), Dizziness Handicap Inventory (DHI), and Quality of Life (SF-36) questionnaires will be included in addition to audiologic tests and speech and language assessments.

Study Drug or Device Procedures:
Subjects will undergo pre-operative evaluation for ABI surgery. Those subjects that are appropriate for surgery will undergo a procedure for implantation of the ABI24 system. As per manufacturer protocol, the parameters of the ABI24 system including adjustment of electrode sensitivities and activation of specific electrodes will be completed at each follow-up visit post-operatively. This process involves adjustment of device parameters by an audiologist who subsequently administers audiologic tests (including psychophysical measures) to confirm optimal activation of the ABI24 device.
 
Standard of Care Procedures:
All audiologic testing and assessments represent the standard of care. Aspects of our study that go beyond routine standard of care are outlined above and in the informed consent.
 
Follow-up Procedures:
Study participants will have audiologic testing and device activation and adjustment completed at follow-up appointments. These post-operative follow-up appointments will occur at 1-2 weeks, 4-12 weeks (initial activation), one week following activation (5-7 weeks), three, six, and twelve months, and biannually thereafter until the study end point of five years. Timing of these appointments may vary by as much as four weeks prior to or after the planned follow-up date (e.g. between 2-4 months for the 3 month follow-up).
For More Information
1-617-573-3130 or abi@meei.harvard.edu

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Please click here to the return to the Otolaryngology - Head and Neck Surgery Department Clinical Research page.

 

 

Page updated 5/30/2013.