Cochlear Implants for Adults With Single-sided Deafness

Study Overview
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Brief Summary
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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 (termed single-sided deaf person, or SSD). The potential subjects will have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The long-term goal of this research program is to determine whether the CI, in combination with the NH ear, may provide improved localization ability and better speech understanding in noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off, after implantation.

Official Title
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Cochlear Implantation for Single-Sided Deafness

Conditions
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Single-sided Deafness

Intervention / Treatment
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* Device: MED-EL Maestro Cochlear Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label<br>Cochlear Implant | Device: MED-EL Maestro Cochlear Implant<br>* cochlear implant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pure-tone threshold average (dB) | Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear. | 6 months post-activation | 
| Hearing in Noise Test (signal-to-noise ratio) | Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear. | 6 months post-activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of unexpected serious adverse events across all 10 subjects. | 1-month post-implantation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deaf adult, single-sided, cochlear implant