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Completed

NCT Number: NCT02698787

Fundamental Asynchronous Stimulus Timing Sound Coding Study

The Fundamental Asynchronous Stimulus Timing (FAST) is a novel cochlear implant sound coding strategy. Potential benefits include improved battery life, in addition to improved localization for bilateral patients.

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Key information

Conditions

Sensorineural 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

Primary location

University of Colorado Health

Aurora, Colorado, 80045, United States

About this study

The Fundamental Asynchronous Stimulus Timing (FAST) strategy offers excellent potential as a low power alternative coding strategy to the current default strategy in Nucleus® cochlear implants, Advanced Combination Encoder (ACE). Additionally, FAST offers potential bilateral benefits - localization and listening in spatially separated noise - because it has been shown in acute, controlled studies to provide more access to interaural timing difference (ITD) cues (Smith, 2010).Previous research with experienced cochlear-implant recipients has shown issues with conversion from ACE to FAST. The FAST strategy typically sounds very different in quality, and acclimatization can be lengthy. This extended adaptation time makes it difficult to show conclusively that FAST is non-inferior to ACE for speech understanding. A potential barrier to evaluating performance with FAST in current cochlear-implant recipients is the extensive amount of prior experience that many recipients have using ACE. Hence, there is a distinct need to evaluate FAST in newly implanted recipients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series implant
  • Post-linguistically deafened
  • Native speaker of American English
  • Eighteen years of age or older

Exclusion criteria

  • Previous or existing cochlear-implant recipient
  • Pre-linguistically deafened (onset of hearing loss at less than two years of age)
  • Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
  • Diagnosis of retro-cochlear pathology
  • Diagnosis of auditory neuropathy
  • Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and use of the prosthetic device
  • Unwillingness or inability to comply with all investigational requirements
  • Additional cognitive handicaps that would delay rate of improvement with the cochlear implant

Treatment and study plan

Experimental sound coding strategy (FAST)

Device

Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Commercially available ACE sound coding strategy

Device

Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy

Primary outcomes

  1. Change in Open Set Monosyllabic Word Recognition Score

    Time frame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)

    Open Set Monosyllabic Word Recognition is a test of 50 words each consisting of 3 individual speech sounds. The subject repeats the word s/he hears to the audiologist. The score is based on the percentage of words correct.

    The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for word recognition in quiet with percentage of words correct.

  2. Change in Signal-to-Noise Ratio (SRT)

    Time frame: Visit 5 (3 Months) and Visit 8 (6 months)

    The primary outcome measure to is determine if the investigational sound coding strategy (FAST) is non-inferior to commercially approved sound coding strategies (ACE) for BKB sentences in noise with mean signal-to-noise ratio (SRT) where participants could understand 50% of sentences in noise using ACE and FAST. Lower SRT values indicate better performance.

    SRT measures are obtained using two types of background noise. One is "Speech-Shaped Noise" which is white noise or tones made to mimic speech. The other is "Four-Talker Noise" which is multiple talkers made to mimic background conversation.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients

Acronym: FAST

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2016
Registry last updated
Feb 2, 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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