Bilateral Hearing Loss for Causes Other Than TumorsNCT01736267

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

A study testing Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI) in people with Bilateral Hearing Loss for Causes Other Than Tumors, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bilateral Hearing Loss for Causes Other Than Tumors
What is being tested?: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 1 siteUnited States
Study dates: Nov 2012to 25 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: Study of Nucleus 24 and ABI541 Auditory Brainstem Implants (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects

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.

Read the 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.

Conditions: Bilateral Hearing Loss for Causes Other Than Tumors
Being tested: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Keywords: Auditory Brainstem Implant, ABI, Nucleus 24, Deafness, Hearing loss, Non-tumor, Non-NF2, ABI541
Medical subject headings: Deafness, Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)Device
Also called ABI, Nucleus 24, Cochlear Americas, ABI541, Nucleus Profile
Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.

Study groups in NCT01736267
Study group	Role	What they receive
Non-NF2 ABI surgery	Experimental	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. Receives: Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 12 months post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201225 Apr 2019

First posted29 Nov 2012 (estimated)
Study startNov 2012
Primary completion25 Apr 2019
Study completion25 Apr 2019

Why it stopped: Closed by IRB

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Bilateral Hearing Loss for Causes Other Than TumorsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01736267
Sponsor's protocol ID: MEEI HSC 12-061
Status last verified: Apr 2020
First submitted: 26 Nov 2012
Last updated: 6 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 20393378
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.
PubMed 19704357
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.
PubMed 22109761
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.
PubMed 19546832

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Nucleus 24 and ABI541 Auditory Brainstem Implants (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
ClinicalTrials.gov ID: NCT01736267
Acronym / sponsor ID: MEEI HSC 12-061
Conditions: Bilateral Hearing Loss for Causes Other Than Tumors
Keywords: Auditory Brainstem Implant, ABI, Nucleus 24, Deafness, Hearing loss, Non-tumor, Non-NF2, ABI541
Study type: Interventional
Recruitment status: TerminatedReason stopped: Closed by IRB
Enrolment: 3 participants (actual)
Lead sponsor: Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
Study start: Nov 2012 (actual)
Primary completion: 25 Apr 2019 (actual)
Study completion: 25 Apr 2019 (actual)
First posted: 29 Nov 2012 (estimated)
Results: Posted 6 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Non-NF2 ABI surgery	Experimental	Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)Also: ABI, Nucleus 24, Cochlear Americas, ABI541, Nucleus ProfileNucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.	Device	Non-NF2 ABI surgery

Primary outcome

Audiologic Performance
Time frame: 12 months post-operative
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).

Results and safety

Results posted to the registry on 6 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-NF2 ABI Surgery	3	3

Primary outcome: Audiologic Performance

Time frame: 12 months post-operative. Number. Unit: dB HL

Measure	Non-NF2 ABI Surgery n = 1
Value	87

Population analysed: We only included data from subjects that had auditory percept of any magnitude following ABI surgery (1/3 subjects).

Adverse events

Time frame: All reported events occurred within one year of when the participant had surgery. Participants were followed through the end of their participation in the study for safety and continue to receive routine medical monitoring for safety as part of their standard care.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-NF2 ABI Surgery	2 of 3 (66.7%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20393378Colletti 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.
Background: PubMed 19704357Sennaroglu 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.
Background: PubMed 22109761Choi 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.
Background: PubMed 19546832Colletti 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel J Lee, MD, FACS principal investigator

MEEI, HMS, MGH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Audiologic Performance (time frame: 12 months post-operative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736267, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2020.