Clinical trial NCT02698787: Fundamental Asynchronous Stimulus Timing Sound Coding Study
Official title: Investigation of the FAST Sound Coding Strategy in Newly Implanted Adult Cochlear Implant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Sensorineural Hearing Loss
Keywords: cochlear implant, sensorineural hearing loss
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2016-03-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Open Set Monosyllabic Word Recognition Score
timeFrame: Visit 1 (baseline), Visit 5 (3 months), Visit 8 (6 months)
measure: Change in Signal-to-Noise Ratio (SRT)
timeFrame: Visit 5 (3 Months) and Visit 8 (6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Health
state: Colorado
Study officials:
References:
citation: Daneman , M., & Carpenter, P.A. (1980). Individual differences in working memory and reading. Journal of Verbal Learning andVerbal Behavior, 19, 450-466.
citation: Noble W, Jensen NS, Naylor G, Bhullar N, Akeroyd MA. A short form of the Speech, Spatial and Qualities of Hearing scale suitable for clinical use: the SSQ12. Int J Audiol. 2013 Jun;52(6):409-12. doi: 10.3109/14992027.2013.781278.
citation: Bench J, Kowal A, Bamford J. The BKB (Bamford-Kowal-Bench) sentence lists for partially-hearing children. Br J Audiol. 1979 Aug;13(3):108-12. doi: 10.3109/03005367909078884.
citation: PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70. doi: 10.1044/jshd.2701.62. No abstract available.
citation: Smith, Z. M. (2010). Improved sensitivity to interaural time differences with the FAST coding strategy. Presented at the 11th International Conference on Cochlear Implants and Other Implantable Auditory Technologies, Stockholm, Sweden.