Status:
UNKNOWN
Cochlear Implants for Adults With Single-sided Deafness
Lead Sponsor:
Robert Shannon
Collaborating Sponsors:
Med-El Corporation
House Clinic, Inc.
Conditions:
Single-sided Deafness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (ter...
Eligibility Criteria
Inclusion
- Is an adult (18 years of age or older)
- English as the primary language
- Able to undergo general anesthesia, as determined by physical examination and written report from the physician
- Receives pneumovax vaccine within 2 weeks of surgery and provides documentation to the principal investigator
- Profoundly/severely deaf in one ear ("implant ear"), as defined by:
- 3-frequency pure-tone average≥70 dB Hearing Loss
- Bone conduction thresholds consistent with air conduction thresholds (i.e., no conductive component to the hearing loss)
- HINT sentence recognition score ≤40% correct, 60 dBA presentation level
- Post-lingual onset of hearing loss, i.e., after age 6 years of age
- Hearing loss occurred \<10 years prior, as obtained by history
- Normal hearing in one ear ("non-implant ear"), as defined by:
- 3-frequency PTA ≤25 dB HL
- No tested frequency air conduction threshold \>35 dB HL
- Bone conduction thresholds consistent with air conduction thresholds
- Word recognition score ≥80% correct, 60 dBA presentation level
- HINT sentence recognition score ≥ 80%, 60 dBA presentation level
- Provides informed consent
- Willing and able to follow the study protocol
Exclusion
- Retrocochlear pathology resulting from Neurofibromatosis 2, or other types of cranial nerve/brainstem tumors
- Co-existing medical conditions that require radiotherapy of the brainstem and/or auditory cortex
- Any medical contraindication precluding safe administration of general anesthesia, e.g.,
- Cardiopulmonary disease
- Renal disease
- Otologic conditions which contraindicate surgery
- Active middle ear infection
- Tympanic membrane perforation
- Anatomic abnormalities detected on CT preventing appropriate placement of the stimulator housing in the bone of the skull or placement of the electrode array in the cochlea (e.g., ossification)
- Psychological conditions contraindicating surgery
- Skin or scalp conditions that may preclude attachment of the coil or that may interfere with the use of the coil
- Chronic pain in or around the head
- Current or previous use of an active hearing implant (e.g., bone-anchored hearing aids, cochlear implant, etc.)
- Developmental delays or organic brain dysfunction
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02259192
Start Date
September 1 2014
End Date
September 1 2019
Last Update
April 20 2017
Active Locations (2)
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1
Keck School of Medicine of USC
Los Angeles, California, United States, 90007
2
House Clinic
Los Angeles, California, United States, 90057