Clinical trial · Interventional
Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
Study of Nucleus 24 and ABI541 Auditory Brainstem Implants (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
NCT01736267CI-TRIAL-00044980terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed by IRB
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bilateral Hearing Loss for Causes Other Than Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Non-NF2 ABI surgery
- 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.
- interventionNames
- Device: Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)
Primary outcomes (1)
- measure
- Audiologic Performance
- timeFrame
- 12 months post-operative
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 womenReferences
Publications (4)
- BACKGROUNDColletti 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. PMID 20393378
- BACKGROUNDSennaroglu 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. PMID 19704357
- BACKGROUNDChoi 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. PMID 22109761
- BACKGROUNDColletti 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. PMID 19546832