Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios

Study Overview
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Brief Summary
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In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Naída Link M90 hearing aid and Naída CI M90 sound processor on sound perception. This design was shown to be successful in previous studies for the evaluation of sound coding strategies. Furthermore, a within-subject comparison decreases the variance in the results allowing for fewer subjects when the population that uses the investigational device is not large in general.

Official Title
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Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios

Conditions
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Cochlear Hearing Loss

Intervention / Treatment
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* Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CI users with a CII, HiRes90K (Advantage) or HiRes Ultra implant system Bilateral users: two implant systems Bimodal users: hearing aid contralateral Minimum of 18 years of age Minimum of six months experience with their implant system Minimum of six months experience with the Naída CI Q-Series sound processor Ability to give feedback on sound quality Speech intelligibility with the HSM sentence test in noise at 10 dB SNR > 10% as obtained during previous visits in the clinical routine Fluent in German language Exclusion Criteria: Difficulties additional to hearing impairment that would interfere with the study procedures Concurrent participation in other study Pregnant and breast-feeding women

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: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral users<br>two implant systemswith two sound processors | Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)<br>* Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback<br>|
| Experimental: Bimodal user<br>with one sound processor and one hearing aid | Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)<br>* Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in speech perception in noise with AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices | Difference in speech reception threshold of 50% speech understanding which is the signal to noise ratio in Decibel [dB] to understand 50% of the target speech between AutoSense OS on Naída M hearing devices and AutoSound OS on the clinically available Naída Q hearing devices. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in speech perception in noise threshold measured in Decibel [dB] | Differences are compared between AutoSense OS on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices. Min and Max values are -10dB and +10dB, whereas the smalller the value the better | 6 weeks | 
| Differences in speech perception in quiet threshold measured in Decibel [dB] | Differences are compared between AutoSense OS on Naída M hearing devices and AutoSound OS on Naída Q hearing devices and the omnidirectional microphone setting on Naída Q hearing devices. Min and Max values are -10dB and +10dB, whereas the smalller the value the better | 6 weeks | 
| Differences in mono/stereo identification measured in % correct | Differences are compared between mono and stereo free-field presentation, mono and stereo streaming presentation, stereo free-field and stereo streaming presentation, mono free-field and mono streaming presentation, differences in music enjoyment ratings measured in rating score | 6 weeks | 
| Differences in speech understanding in noise measured in % correct | Differences are compared between AutoZoomControl on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices | 6 weeks | 
| Differences in music enjoyment ratings measured in rating score | Differences are compared between mono and stereo free-field presentation mono and stereo streaming presentation stereo free-field and stereo streaming presentation mono free-field and mono streaming presentation | 6 weeks |