Fundamental Asynchronous Stimulus Timing Sound Coding Study

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Brief Title

Fundamental Asynchronous Stimulus Timing Sound Coding Study

Official Title

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

Brief Summary

      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.

Detailed Description

      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.

Study Type


Primary Outcome

Change in Open Set Monosyllabic Word Recognition Score


Sensorineural Hearing Loss


Experimental sound coding strategy (FAST)

Study Arms / Comparison Groups

 Group 1
Description:  All patients will be receiving commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with Contour Advance™ Electrode for this study. Group 1 will be receiving the FAST (experimental) sound coding strategy at initial activation and use it for the first three months.At the three month interval subjects in Group 1 will be switched to the commercially available ACE (control) sound coding strategy.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 2015

Completion Date

November 19, 2018

Primary Completion Date

November 19, 2018

Eligibility Criteria

        Inclusion Criteria

          -  Medical and audiological candidate for a unilateral CI24RE, CI512 or CI532 series

          -  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




18 Years - N/A

Accepts Healthy Volunteers



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Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor


Study Sponsor

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Verification Date

January 2021