Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01736267|
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Bilateral Hearing Loss for Causes Other Than Tumors||Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Nucleus 24 and ABI541 Auditory Brainstem Implants (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2022|
Experimental: Non-NF2 ABI surgery
All subjects will be part of a single arm involving placement of the Nucleus ABI541 Auditory Brainstem Implant (ABI) device. The Nucleus 24 was discontinued and is no longer available.
Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.
Other Name: ABI, Nucleus 24, Cochlear Americas, ABI541, Nucleus Profile
- Perioperative and postoperative complications [ Time Frame: 5 years from date of surgery ]We will track any major and minor complications intraoperatively and postoperatively in all study participants.
- Audiologic performance [ Time Frame: 5 years from date of surgery ]We will complete physiological, psychophysical, and speech based tests to determine audiologic performance following ABI surgery.
- ABI electrophysiologic parameters [ Time Frame: 5 years from date of surgery ]We will examine parameters for electrode activation postoperatively in all study participants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736267
|Contact: Daniel J Lee, MD, FACSfirstname.lastname@example.org|
|Contact: Barbara S Herrmann, PhD, CCC-Aemail@example.com|
|United States, Massachusetts|
|Massachusetts Eye and Ear Infirmary||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Daniel Lee, MD, FACS 617-573-3130 firstname.lastname@example.org|
|Contact: Sidharth Puram, MD 617-571-4049 Sidharth_Puram@MEEI.HARVARD.EDU|
|Principal Investigator: Daniel J Lee, MD, FACS|
|Sub-Investigator: Barbara Herrmann, PhD, CCC-A|
|Sub-Investigator: Sidharth V Puram, MD|
|Principal Investigator:||Daniel J Lee, MD, FACS||MEEI, HMS, MGH|