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OpenTrials
Completed

NCT Number: NCT04815343

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

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.

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Key information

Conditions

Cochlear Hearing Loss Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Hochschule Hannover (MHH)

Hanover, Lower Saxony, 30625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)

Device

Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Advanced Bionics AG

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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