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OpenTrials
Completed

NCT Number: NCT04610216

Investigation of the Automatic Technology on the Naída M Hearing Devices

In this clinical trial, an un-controlled, repeated measures open design with within-subject comparison will be used to evaluate the effect of the device under investigation 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 using 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

Observational

Primary location

Hôpitaux Universitaires de Genève (HUG)

Geneva, 1211, Switzerland

About this study

The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices.The Naída CI M90 sound processor is a behind-the-ear (BTE) sound processor based on the Phonak Marvel hearing aid platform. It replaces the market approved Naída CI Q-Series processors. The Naída Link M90 hearing aid is a behind-the-ear (BTE) hearing aid based on the Phonak Marvel hearing aid platform. It is especially designed to be used for bimodal CI users equipped with a Naída CI M90 sound processor.

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 (3D) 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 reception thresholds of no more than 5 dB SNR > 10 at the French Matrix test obtained during previous visits in the clinical routine
  • Fluent in French language

Exclusion criteria

  • Difficulties additional to hearing impairment that would interfere with the study procedures
  • Concurrent participation in other study
  • Incapacity for consent

Treatment and study plan

Naida CI M hearing device

Device

speech intelligibility measurement with Naida CI M hearing device

Primary outcomes

  1. Difference in speech intelligibility in noise

    Time frame: 2 months

    The primary endpoint of this clinical investigation is the difference in speech intelligibility measured in percent correct with AutoZoomControl compared to an omnidirectional microphone on Naída M hearing devices. The French Matrix Test will be used and percentage correct will be recorded.

Secondary outcomes

  1. Differences in speech perception in noise

    Time frame: 2 months

    ZoomControl versus Omnidirectional microphone and AutoZoomControl versus ZoomControlon Naída M hearing devices will be compared.

    The French Matrix Test will be used and percentage correct will be recorded.

  2. Differences in localization abilities

    Time frame: 2 months

    AutoZoom control versus Omnidirectional microphone, ZoomControl versus Omnidirectional microphone and AutoZoomControl versus ZoomControlon Naída M hearing devices will be compared.

    The directions (0,+/-90,180 degrees) from where the sentences of the French Matrix Test are presented have to be determined.

    Percentage correct will be recorded.

Sponsors and collaborators

Lead sponsor

Advanced Bionics AG

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 30, 2020
Registry last updated
May 1, 2024

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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