Back to resultsInvestigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Primary Purpose
Cochlear Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Sponsored by
About this trial
This is an interventional other trial for Cochlear Hearing Loss
Eligibility Criteria
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
Sites / Locations
- Medizinische Hochschule Hannover (MHH)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Bilateral users
Bimodal user
Arm Description
two implant systemswith two sound processors
with one sound processor and one hearing aid
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04815343
Brief Title
Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Official Title
Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
August 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Bionics AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cochlear Hearing Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral users
Arm Type
Experimental
Arm Description
two implant systemswith two sound processors
Arm Title
Bimodal user
Arm Type
Experimental
Arm Description
with one sound processor and one hearing aid
Intervention Type
Device
Intervention Name(s)
Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Intervention Description
Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Differences in speech perception in noise threshold measured in Decibel [dB]
Description
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
Time Frame
6 weeks
Title
Differences in speech perception in quiet threshold measured in Decibel [dB]
Description
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
Time Frame
6 weeks
Title
Differences in mono/stereo identification measured in % correct
Description
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
Time Frame
6 weeks
Title
Differences in speech understanding in noise measured in % correct
Description
Differences are compared between AutoZoomControl on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices
Time Frame
6 weeks
Title
Differences in music enjoyment ratings measured in rating score
Description
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
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Medizinische Hochschule Hannover (MHH)
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
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