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Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

Primary Purpose

Bilateral Hearing Loss for Causes Other Than Tumors

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bilateral Hearing Loss for Causes Other Than Tumors focused on measuring Auditory Brainstem Implant, ABI, Nucleus 24, Deafness, Hearing loss, Non-tumor, Non-NF2, ABI541

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • 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.

    • 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

Sites / Locations

  • Massachusetts Eye and Ear Infirmary

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-NF2 ABI surgery

Arm Description

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.

Outcomes

Primary Outcome Measures

Audiologic Performance
Average pure tone threshold measured 12 months post-operatively. Measured in dB HL, where a lower threshold indicates more sensitive hearing and a higher threshold indicates less sensitive hearing. We only included data from subjects that had auditory percept of any magnitude following ABI surgery (1/3 subjects).

Secondary Outcome Measures

Full Information

First Posted
November 26, 2012
Last Updated
April 23, 2020
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT01736267
Brief Title
Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
Official Title
Study of Nucleus 24 and ABI541 Auditory Brainstem Implants (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Closed by IRB
Study Start Date
November 2012 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to determine whether Auditory Brainstem Implant (ABI) can improve hearing in persons who are deaf in both ears and are not candidates for cochlear implants.
Detailed Description
The goal of this MEEI Auditory Brainstem Implant (ABI) research study is to find new ways to improve hearing in patients 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. Patients who do not have NF2 and are deaf due to damage to the hearing nerves or inner ears from 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 patients 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 patients, characterize the parameters used on their devices, and determine the safety profile of ABIs in these patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Hearing Loss for Causes Other Than Tumors
Keywords
Auditory Brainstem Implant, ABI, Nucleus 24, Deafness, Hearing loss, Non-tumor, Non-NF2, ABI541

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-NF2 ABI surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Other Intervention Name(s)
ABI, Nucleus 24, Cochlear Americas, ABI541, Nucleus Profile
Intervention Description
Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.
Primary Outcome Measure Information:
Title
Audiologic Performance
Description
Average pure tone threshold measured 12 months post-operatively. Measured in dB HL, where a lower threshold indicates more sensitive hearing and a higher threshold indicates less sensitive hearing. We only included data from subjects that had auditory percept of any magnitude following ABI surgery (1/3 subjects).
Time Frame
12 months post-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J Lee, MD, FACS
Organizational Affiliation
MEEI, HMS, MGH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20393378
Citation
Colletti V, Shannon RV, Carner M, Veronese S, Colletti L. Complications in auditory brainstem implant surgery in adults and children. Otol Neurotol. 2010 Jun;31(4):558-64. doi: 10.1097/MAO.0b013e3181db7055.
Results Reference
background
PubMed Identifier
19704357
Citation
Sennaroglu L, Ziyal I, Atas A, Sennaroglu G, Yucel E, Sevinc S, Ekin MC, Sarac S, Atay G, Ozgen B, Ozcan OE, Belgin E, Colletti V, Turan E. Preliminary results of auditory brainstem implantation in prelingually deaf children with inner ear malformations including severe stenosis of the cochlear aperture and aplasia of the cochlear nerve. Otol Neurotol. 2009 Sep;30(6):708-15. doi: 10.1097/MAO.0b013e3181b07d41.
Results Reference
background
PubMed Identifier
22109761
Citation
Choi JY, Song MH, Jeon JH, Lee WS, Chang JW. Early surgical results of auditory brainstem implantation in nontumor patients. Laryngoscope. 2011 Dec;121(12):2610-8. doi: 10.1002/lary.22137.
Results Reference
background
PubMed Identifier
19546832
Citation
Colletti V, Shannon R, Carner M, Veronese S, Colletti L. Outcomes in nontumor adults fitted with the auditory brainstem implant: 10 years' experience. Otol Neurotol. 2009 Aug;30(5):614-8. doi: 10.1097/MAO.0b013e3181a864f2.
Results Reference
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Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

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