Trials / Withdrawn
WithdrawnNCT01850225
Feasibility Study of Auditory Brainstem Implant in Young Children
A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- House Research Institute · Academic / Other
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities are limited, and in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.
Conditions
- Bilateral Cochlear Aplasia
- Bilateral Cochlear Nerve Deficiency
- Bilateral Cochlear Ossification Secondary to Meningitis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Auditory brainstem implant |
Timeline
- Start date
- 2013-10-01
- Primary completion
- 2015-09-01
- Completion
- 2017-09-01
- First posted
- 2013-05-09
- Last updated
- 2015-03-18
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01850225. Inclusion in this directory is not an endorsement.