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

Sponsor
Advanced Bionics AG (Industry)
Overall Status
Completed
CT.gov ID
NCT04815343
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
8.6
Actual Duration (Months)
2.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
 N/A

Study Design

Study Type:
Interventional
Actual 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)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 :
Nov 20, 2020
Actual Primary Completion Date :
May 1, 2021
Actual Study Completion Date :
Aug 9, 2021

Arms and Interventions

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

Outcome Measures

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 [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] [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] [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Medizinische Hochschule Hannover (MHH) Hannover Niedersachsen Germany 30625

Sponsors and Collaborators

  • Advanced Bionics AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Advanced Bionics AG
ClinicalTrials.gov Identifier:
NCT04815343
Other Study ID Numbers:
  • ABIntl-20-04
First Posted:
Mar 25, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sensorineural

Study Results

No Results Posted as of Nov 24, 2021