Investigation of the Na da CI M90 Sound Processor in Various Acoustic Scenarios

  • STATUS
    Recruiting
  • days left to enroll
    11
  • participants needed
    20
  • sponsor
    Advanced Bionics AG
Updated on 2 April 2021

Summary

In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of Nada Link M90 hearing aid and Nada 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.

Details
Condition Sensorineural hearing loss, Hearing Loss, Auditory Loss and Deafness, Hearing Impairment
Treatment Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)
Clinical Study IdentifierNCT04815343
SponsorAdvanced Bionics AG
Last Modified on2 April 2021

Eligibility

Yes No Not Sure

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 Nada 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
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