Auditory Brainstem Implant (ABI) in Adult Non-Neurofibromatosis Type 2 Subjects
Stopped early · Not applicable
Conditions studied: Bilateral Hearing Loss for Causes Other Than Tumors
In brief
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.
Key facts
- Study ID
- NCT01736267
- Run by
- Massachusetts Eye and Ear Infirmary
- People needed
- 3
- Starts
- 2012-11-01
- Expected to finish
- 2019-04-25
- Last updated by the study team
- 2020-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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