N/A
Completed N=11
Fundamental Asynchronous Stimulus Timing Sound Coding Study
Source: ClinicalTrials.gov NCT02698787 ↗Enrolled (actual)
11
Serious AEs
3.0%
Results posted
Feb 2021
Primary outcomePrimary: Change in Open Set Monosyllabic Word Recognition Score — 5; 11.8; 20.2; 21.4 percentage of words correct
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Open Set Monosyllabic Word Recognition Score |
5; 11.8; 20.2; 21.4; 45; 59.4 | — |
| PRIMARY Change in Signal-to-Noise Ratio (SRT) |
16.3; 16.3; 11.2; 10.1; 13.1; 12.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02698787). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.