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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

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.

Condition or disease Intervention/treatment Phase
Cochlear Hearing Loss Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Official Title: Investigation of the Naída CI M90 Sound Processor in Various Acoustic Scenarios
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hearing Aids

Arm Intervention/treatment
Experimental: Bilateral users
two implant systemswith two sound processors
Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback

Experimental: Bimodal user
with one sound processor and one hearing aid
Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


  2. 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


  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04815343


Contacts
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Contact: Martina Brendel +49 511 524875-24 martina.brendel@advancedbionics.com
Contact: Cyrill Reber +41 58 928 78 66

Locations
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Germany
Medizinische Hochschule Hannover (MHH) Recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Andreas Büchner, Prof.    +49 511 532-6603      
Sponsors and Collaborators
Advanced Bionics AG
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Responsible Party: Advanced Bionics AG
ClinicalTrials.gov Identifier: NCT04815343    
Other Study ID Numbers: ABIntl-20-04
First Posted: March 25, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases