Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness

Study Overview
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Brief Summary
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The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is that restoration of hearing in the deafened ear will result in improved speech perception in the treated ear and advantages related to restoration of hearing to both ears.

Conditions
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Single Sided Deafness

Intervention / Treatment
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* Device: Cochlear Nucleus Cochlear Implant System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide informed consent. Eighteen years-of-age or older at the time of implantation. Presence of single-sided deafness as follows: Poorer ear (ear to be implanted): severe to profound sensorineural hearing loss, defined as pure-tone thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz. Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 10%. Better ear (contralateral ear): Normal or near-normal hearing, defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz. Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 90%. Duration of severe to profound sensorineural hearing loss of at least 6 months (to ensure stability of hearing loss) but no greater than 10 years. English spoken as a primary language. Exclusion Criteria: Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator. Actively using an implantable device in the poorer ear. Onset of severe to profound hearing loss < 6 years-of-age. Evidence of active middle-ear pathology based on otologic examination and/or immittance testing. Medical or psychological conditions that contraindicate undergoing surgery. Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array. Hearing loss of neural or central origin, including auditory neuropathy. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure, as determined by the investigator.

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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cochlear Implantation<br>Cochlear Nucleus Cochlear Implant System | Device: Cochlear Nucleus Cochlear Implant System<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events | Device and procedure-related anticipated and unanticipated aderse events. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing in Noise Test (HINT)Score | To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single sided deafness, Unilateral deafness, Unilateral hearing loss, Cochlear implantation