Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System

Study Overview
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Brief Summary
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The study aims to compare two different cochlear implant sound processing strategies. All the participants will start off with a sound processing strategy called the XDP (extended performance). At the 3 month stage, half of the participants would randomly be selected and offered a sound processing strategy called the Voice Guard. Following that, the sound processing strategies will be altered and evaluated every 3 months at the 6th, 9th and 12th month of cochlear implant use.

Detailed Description
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Voice Guard and XDP are two different cochlear implant sound processing strategies. The Voice Guard sound coding strategy is adaptive in nature and can alter the output from the cochlear implant based on the levels of the listening environment. Hence, it can adapt to soft, medium or conversational and loud speech levels.The XDP on the other hand is not adaptive and cannot alter the cochlear implant output according to the levels of the listening environment. In the study we are hypothesising that the Voice Guard sound processing strategy will perform better than the XDP strategy for soft (40 dB SPL) and loud (85 dB SPL) speech input levels. Speech perception scores will be recorded at 40, 65 and 85 dB SPL and a cross over study design has been adopted. In addition, the efficacy of a cochlear implant sound reduction technique called Voice Track will also be evaluated. The Voice Track is designed to reduce the adverse effect of background noise on cochlear implant speech perception.

Official Title
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Voice Guard Processing Evaluation in a Cohort of Subjects Implanted With the Neuro Cochlear Implant System

Conditions
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Cochlear Implantation

Intervention / Treatment
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* Device: XDP sound processing strategy - Period 0
* Device: XDP sound processing strategy - Period 1
* Device: VG sound processing strategy - Period 1
* Device: XDP sound processing strategy - Period 2
* Device: VG sound processing strategy - Period 2
* Device: XDP sound processing strategy - Period 3
* Device: VG sound processing strategy - Period 3
* Device: Voice Track


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals aged between 18 and 70 years Individuals with post-lingual hearing loss Individuals with no language and speech production disorders Individuals who are native speakers of English Individuals meeting NICE candidacy criteria for CI surgery Individuals undergoing primary unilateral cochlear implantation Exclusion Criteria: Medical conditions contraindicating CI surgery Individuals with anatomical anomalies of the auditory system Individuals with additional mental health issues or and/or cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A-B-A vs B-A-B
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XDP - VG - XDP<br>order of testing: XDP - VG - XDP | Device: XDP sound processing strategy - Period 0<br>* XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.<br>Device: XDP sound processing strategy - Period 1<br>* XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.<br>Device: VG sound processing strategy - Period 2<br>* Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend<br>Device: XDP sound processing strategy - Period 3<br>* XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.<br>Device: Voice Track<br>* Voice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants<br>|
| Experimental: VG - XDP - VG<br>order of testing: VG - XDP - VG | Device: XDP sound processing strategy - Period 0<br>* XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.<br>Device: VG sound processing strategy - Period 1<br>* Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.<br>Device: XDP sound processing strategy - Period 2<br>* XDP is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend.<br>Device: VG sound processing strategy - Period 3<br>* Voice Guard is a cochlear implant sound processing strategy that coverts environmental sound into meaningful information that a cochlear implant users' brain can comprehend<br>Device: Voice Track<br>* Voice Track is a cochlear implant noise cancellation system which is designed to reduce the adverse effect of background noise on speech perception through cochlear implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speech perception scores in quite and in noise | Speech perception with each intervention will be measured and a score between 0 to 100% will be obtained | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcome measure | Glasgow Hearing aid Benefit profile will be administered to assess patient reported benefit with each intervention | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sound processing strategy