Cochlear Implant Low Power Strategy

Study Overview
=================
Brief Summary
-----------------
Reducing power consumption in the cochlear implant is crucial to the development of future smaller sound processors. The commercial MP3000 sound coding strategy has been shown to be more efficient in power consumption to the standard ACE strategy. However in order to develop smaller sound processors, further battery life power savings are required. The aim of this study is to evaluate three experimental sets of MP3000 parameter sets, compared against the default ACE program. In the background for each of the four strategies, experimental noise reduction programs (SpatialNR and NR3) will also be in use. In an additional phase of the study, low stimulation rate ACE programs will also be evaluated against the default stimulation rate.

Official Title
-----------------
Clinical Assessment of a Low Power Strategy for Cochlear Implant Recipients

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: MP3000 sound coding strategy or ACE strategy with lower stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (>18 years) cochlear implant recipients Implanted with the CI500, CI24RE and Nucleus 24 Series and CI422 cochlear implants. User of commercially available Freedom, CP810 or CP900 series sound processor User of the ACE strategy or MP3000 strategy At least 3 months experience with the cochlear implant Native speaker in the language used to assess speech perception performance Willingness to participate in and to comply with all requirements of the protocol Exclusion Criteria: Additional handicaps that would prevent participation in evaluations Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MP3000-ACE strategy<br>MP3000 sound coding strategy or ACE strategy with lower stimulation rate | Device: MP3000 sound coding strategy or ACE strategy with lower stimulation<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Word recognition scores in quiet | Word recognition scores in quiet for i) MP3000 strategy compared to default ACE strategy and ii) lower rate stimulation for ACE strategy | Testing over 18 weeks | 
| Sentence recognition scores in quiet | Sentence recognition scores in quiet for i) MP3000 strategy compared to ACE strategy and ii) lower rate stimulation for ACE strategy | Testing over 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fundamental frequency (F0) discrimination | F0 discrimination for MP3000 strategy compared to the ACE baseline | Testing over 18 weeks | 
| Speech intelligibility and helpfulness subjective ratings | For MP3000 strategy compared to the default ACE baseline | Testing over 18 weeks | 
| Sentence in noise scores | Comparison of MP3000 program with Spatial NR and NR3 enabled versus disabled. | Testing over 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cochlear implants, power consumption,