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

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ClinicalTrials.gov Identifier: NCT04815343
Recruitment Status : Recruiting
First Posted : March 25, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Advanced Bionics AG

Tracking Information
First Submitted Date  ICMJE March 19, 2021
First Posted Date  ICMJE March 25, 2021
Last Update Posted Date March 26, 2021
Actual Study Start Date  ICMJE November 20, 2020
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
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 [ Time Frame: 6 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2021)
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 [ Time Frame: 6 weeks ]
Difference in speech reception threshold of 50% speech understanding which is the signal to noise ratio in 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2021)
  • Differences in speech perception in noise threshold measured in Decibel [dB] [ Time Frame: 6 weeks ]
    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] [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6 weeks ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2021)
  • Differences in speech perception in noise threshold measured in dB [ Time Frame: 6 weeks ]
    Differences are compared between AutoSense OS on Naída M hearing devices and the omnidirectional microphone setting on Naída Q hearing devices
  • Differences in speech perception in quiet threshold measured in dB [ Time Frame: 6 weeks ]
    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
  • Differences in mono/stereo identification measured in % correct [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6 weeks ]
    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 [ Time Frame: 6 weeks ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Official Title  ICMJE Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
comparision of different conditions with-in subject. (10 bimodal, 10 bilateral CI users)
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cochlear Hearing Loss
Intervention  ICMJE Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback
Study Arms  ICMJE
  • Experimental: Bilateral users
    two implant systemswith two sound processors
    Intervention: Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
  • Experimental: Bimodal user
    with one sound processor and one hearing aid
    Intervention: Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 22, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Martina Brendel +49 511 524875-24 martina.brendel@advancedbionics.com
Contact: Cyrill Reber +41 58 928 78 66
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04815343
Other Study ID Numbers  ICMJE ABIntl-20-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Advanced Bionics AG
Study Sponsor  ICMJE Advanced Bionics AG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Advanced Bionics AG
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP