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Completed

NCT Number: NCT04237207

Clinical Evaluation of a Cochlear Implant Sound Processor

This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders 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

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States

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About this study

The overall goal of this clinical study is to demonstrate the safety and efficacy of a cochlear implant sound processor. Hearing outcomes are expected to be similar non-inferior to as compared to the currently approved software and processors. Therefore, the study described herein uses a non-inferiority design to determine whether sentence recognition in quiet and in noise is no worse with the new sound processor than with currently approved software on a Q90 processor.

Who can participate

Healthy volunteers accepted: No

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

General Inclusion Criteria:

  • Ability to provide Informed Consent
  • 18 years of age or older
  • Unilateral user of a HiResolutionTM Bionic Ear System (HiRes 90KTM, HiRes 90KTM Advantage, HiResTM Ultra, HiResTM Ultra 3D), including bilaterally implanted subjects that only use one implant in their everyday listening modality
  • Minimum of 6 months of CI experience
  • Having used a Naída CI Q70 or a Naída CI Q90 as their primary processor for a minimum of one month
  • Presently using a current steering strategy
  • At least moderate open-set speech recognition abilities with implant alone, as defined by achieving a score of ≥ 60% words correct in the AzBio in quiet test using the Naída CI Q90 research processor
  • English language proficiency as determined by the investigator
  • Willingness to use a BTE processor for the duration of the study

ARH Arm Inclusion Criteria

  • Residual low frequency hearing sensitivity (pure tone average of < 70 dB HL for 125, 250, and 500 Hz) and a severe-to-profound high-frequency sensorineural hearing loss (pure tone average of ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear
  • Willingness to use an in-canal acoustic earhook for the duration of the study

EO Arm Inclusion Criteria

  • Severe-to-profound sensorineural hearing loss in the low (pure tone average of ≥ 70 dB HL for 125, 250, and 500 Hz) and high frequencies (pure tone average ≥ 70 dB HL for 1,000, 2,000, 3000, 4,000, and 8,000 Hz) in the implanted ear

Exclusion criteria

  • Unrealistic expectations regarding potential benefits, risks and limitations of the investigational device as determined by the investigator
  • Unwillingness or physical / cognitive inability of subject to comply with all investigational requirements as determined by the investigator

Treatment and study plan

Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software

Device

Control cochlear implant sound processor

301-M062 sound processor & software

Device

New cochlear implant sound processor

Primary outcomes

  1. Speech Recognition in Quiet

    Time frame: 1 Day

    The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

Secondary outcomes

  1. Speech Recognition in Noise

    Time frame: 1 Day

    Demonstrate that AzBio sentence recognition scores in noise with the new sound processor are no worse than AzBio sentence recognition scores in noise with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

  2. Increased Speech Recognition in Noise

    Time frame: 1 Day

    Demonstrate increased AzBio sentence recognition scores in noise with the new sound processor when comparing "Omnidirectional" program to AutoSense. Omnidirectional refers to a setting in which the AutoSense feature is not active. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

Sponsors and collaborators

Lead sponsor

Advanced Bionics

Industry

Registry information

Official study title

Evaluation of AutoSense OS on a Cochlear Implant Sound Processor Programmed With Target CI Fitting Software in Adult Users of the HiResolution Bionic Ear System

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
May 13, 2022

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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