Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
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ClinicalTrials.gov Identifier: NCT01736267 |
Recruitment Status
:
Recruiting
First Posted
: November 29, 2012
Last Update Posted
: March 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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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) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.
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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
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- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years of age or older
- English as the primary language
- Medically and psychologically suitable
- Willing to receive/have received meningitis / pneumococcal vaccinations
- Able to comply with study requirements, including travel to the investigational site
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Cochlear or retrocochlear anomaly/pathology that interferes with transmission of auditory information from the cochleae to the brainstem, resulting in severe to profound bilateral deafness (thresholds of 90 dB or worse in both ears on pure tone audiometry ranging from 250 to 2,000 Hz and speech recognition scores ≤ 30% in both ears). All subjects will undergo bone conduction audiometry and tympanometry to confirm sensorineural hearing loss and rule out potential middle ear disorders.
- Conditions that cannot be otherwise treated, with conventional hearing aids or cochlear implants. If CI were previously used, subjects will have had a failed response, defined as ≤ 30% speech recognition and patient perception of inadequate benefit to continue using the device.
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Expected subjects include those with these diagnoses:
- Bilaterally severe/completely ossified cochleae
- Bilateral cochlear malformations leading to poor CI outcomes
- Bilateral temporal bone fractures, where the VIIIth cranial nerves have been disrupted
- Bilateral cochlear nerve agenesis
- Not a CI candidate based on above listed pathology, intolerable adverse effects with CI (e.g. stimulation of the facial nerve), or Evoked Auditory Potential testing predictive of a poor response
Exclusion Criteria:
- Anomalies/pathology involving the brainstem or cortex
- Retrocochlear pathology due to NF2 or other types of cranial nerve or brainstem neoplasm
- Co-existing medical conditions that require irradiation of the brainstem or auditory cortex
- Medical or psychological conditions that serve as contraindication to surgery
- Additional handicaps that would prevent or limit participation in evaluations
- Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
- Pregnant women

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, FACS | 617-573-3130 | daniel_lee@meei.harvard.edu | |
Contact: Barbara S Herrmann, PhD, CCC-A | 617-573-3266 | barbara_herrmann@meei.harvard.edu |
United States, Massachusetts | |
Massachusetts Eye and Ear Infirmary | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Daniel Lee, MD, FACS 617-573-3130 daniel_lee@meei.harvard.edu | |
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 |
Additional Information:
Publications:
Responsible Party: | Dr. Daniel Lee, Director of Auditory Brainstem Implant Progra, Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Massachusetts Eye and Ear Infirmary |
ClinicalTrials.gov Identifier: | NCT01736267 History of Changes |
Other Study ID Numbers: |
MEEI HSC 12-061 |
First Posted: | November 29, 2012 Key Record Dates |
Last Update Posted: | March 13, 2018 |
Last Verified: | March 2018 |
Keywords provided by Dr. Daniel Lee, Massachusetts Eye and Ear Infirmary:
Auditory Brainstem Implant ABI Nucleus 24 Deafness |
Hearing loss Non-tumor Non-NF2 ABI541 |
Additional relevant MeSH terms:
Hearing Loss Deafness Hearing Loss, Bilateral Hearing Disorders Ear Diseases |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |